Menu

Search Results for: drug approval

pablo (44)

New FDA Drug Approvals for 1st Quarter 2019

The following medications have been approved this year for disease states including various cancers, migraine, hemophillia, arthritis, MS, and sleep apnea to name a few. Read more below about the drugs and their possible side effects.

Jatenzo (testosterone undecanoate) from Clarus Therapeutics was approved in March for the treatment of male conditions associated with a deficiency or absence of endogenous testosterone.

Adverse effects associated with the use of Jatenzo may include, but are not limited to, the following:

  • polycythemia
  • diarrhea
  • dyspepsia
  • eructation
  • peripheral edema
  • nausea
  • increased hematocrit
  • headache
  • prostatomegaly
  • hypertension

Adults with acute migraine may find relief with Tosymra (sumatriptan) nasal spray from Dr. Reddy’s Labs. This nasal spray can be used for migraine with or without aura. Side effects may include:

  • tingling
  • dizziness
  • feeling warm or hot
  • burning feeling
  • feeling of heaviness
  • feeling of pressure
  • flushing
  • feeling of tightness
  • numbness
  • application site (nasal) reactions
  • abnormal taste
  • throat irritation

Esperoct [antihemophilic factor (recombinant), glycopegylated-exei] from Novo Nordisk was approved in February for the treatment of hemophilia A. Esperoct is specifically indicated for use in adults and children with hemophilia A for on-demand treatment and control of bleeding episodes,  perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes.

Adverse effects associated with the use of Esperoct may include, but are not limited to:

  • rash
  • redness
  • itching
  • injection site reaction

In February, Cablivi (caplacizumab-yhdp) by Ablynx has been approved for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura (aTTP), in combination with plasma exchange and immunosuppressive therapy.

Adverse effects associated with the use of Cablivi may include, but are not limited to:

  • epistaxis
  • headache
  • gingival bleeding

Cimzia (certolizumab pegol) by UCB was approved in March for the treatment of non-radiographic axial spondyloarthritis which is inflammatory arthritis with one distinguishing feature, there is almost always inflammation in the spine. Cimzia comes with a black box warning, and other adverse side effects which may include:

  • upper respiratory tract infection
  • rash
  • urinary tract infection

Two new drugs for the treatment of relapsing multiple sclerosis were approved in March.

Mavenclad (cladribine)  from Merck. Mavenclad is specifically indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults. Because of its safety profile, use of Mavenclad is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, an alternate drug indicated for the treatment of MS. Side effects may include:

  • upper respiratory tract infection
  • headache
  • lymphopenia

Mayzent (siponimod) by Novartis is specifically indicated for the treatment of relapsing forms of MS, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. Side effects may include:

  • headache
  • hypertension
  • transaminase increases

Spravato (esketamine) nasal spray by Janssen Pharmaceuticals was approved in March for the treatment of treatment-resistant depression in adults. This nasal spray is specifically indicated for use in conjunction with an oral antidepressant. It contains a black box warning and has many potential side effects including:

  • dissociation
  • dizziness
  • nausea
  • sedation
  • vertigo
  • hypoesthesia
  • anxiety
  • lethargy
  • blood pressure increased
  • vomiting
  • feeling drunk

Women suffering from postpartum depression may find relief with Zulresso (brexanolone) from Sage Therapeutics. Approved in March 2019 Zulresso (brexanolone) is a neuroactive steroid gamma-aminobutyric acid (GABA) A receptor positive modulator.

Zulresso is supplied as a solution for intravenous administration. Administer Zulresso as a continuous intravenous (IV) infusion over a total of 60 hours (2.5 days) as follows:

Adverse effects associated with the use of Zulresso may include, but are not limited to:

  • sedation/somnolence
  • dry mouth
  • loss of consciousness
  • flushing/hot flush

If you suffer from excessive daytime sleepiness due to narcolepsy or obstructive sleep apnea (OSA), Sunosi (solriamfetol) from Jazz Pharmaceutical has been approved. Sunosi (solriamfetol) is a dopamine and norepinephrine reuptake inhibitor and is specifically indicated to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or OSA.

Adverse effects associated with the use of Sunosi may include, but are not limited to:

  • headache
  • nausea
  • decreased appetite
  • insomnia
  • anxiety

Herceptin Hylecta (trastuzumab and hyaluronidase-oysk) by Halozyme was approved in February for the treatment of HER2-overexpressing breast cancer and Metastatic Breast Cancer. However, it comes with a black box warning and the following potential side effects:

  • fatigue
  • arthralgia
  • diarrhea
  • injection site reaction
  • upper respiratory tract infection
  • rash
  • myalgia
  • nausea
  • headache
  • edema
  • flushing
  • pyrexia
  • cough
  • pain in extremity
  • fever
  • chills
  • headache
  • infection
  • congestive heart failure
  • insomnia
  • cough
  • rash

Tecentriq (atezolizumab) by Genentech/Roche has been approved for the treatment of extensive-stage small cell lung cancer. Tecentriq (atezolizumab) is a monoclonal antibody designed to bind with a protein called PD-L1.

Tecentriq is specifically indicated for use in combination with carboplatin and etoposide, for the initial (first-line) treatment of adults with extensive-stage small cell lung cancer (ES-SCLC).

Tecentriq is supplied as an injection for intravenous administration. Adverse effects associated with the use of Tecentriq in combination with chemotherapy for use on ES-SCLC may include, but are not limited to:

  • fatigue/asthenia
  • nausea
  • alopecia
  • constipation
  • diarrhea
  • decreased appetite

Rocklatan (netarsudil and latanoprost ophthalmic solution) from Aerie Pharmaceuticals has been approved for the treatment of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Rocklatan is a fixed-dose combination of latanoprost, a prostaglandin analog (PGA), and netarsudil, a first-in-class Rho kinase (ROCK) inhibitor.

Adverse effects associated with the use of Rocklatan may include, but are not limited to:

  • conjunctival hyperemia
  • instillation site pain
  • corneal verticillata
  • conjunctival hemorrhage


Newest Drug Approvals

The FDA has recently approved the following medications:
Brineura from BioMarin was approved in April for the treatment of late infantile neuronal ceroid lipofuscinosis type 2 (CLN2). This fatal genetic neurodegenerative disease affects 1 in 12,500 live births and  Brineura is specifically indicated to slow the loss of ambulation in symptomatic pediatric patients 3 years of age and older with with late CLN2 and is indicated to improve the quality of life of the young patients.
For the treatment of adult patients with newly diagnosed acute myeloid leukemia and mastocytosis who are FLT3 positive, Rydapt from Novartis was approved in April 2017. Rydapt is specifically indicated to work in combination with certain chemotherapy for the treatment of adult patients with newly diagnosed acute myeloid leukemia who are FLT3 mutation positive. It is also indicated for the treatment of adult patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia.
Patients with ocular itching associated allergic conjunctivitis, Zerviate from NicOx was approved by the FDA. This topical antihistamine reduces swelling, itching and, and dilation of blood vessels in the eye.
Kevara from Sanofi was approved in May for the treatment of active rheumatoid arthritis.
Kevzara is specifically indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs). Kevzara may be used as monotherapy or in combination with methotrexate (MTX) or other conventional DMARDs. The recommended dosage of Kevzara is 200 mg once every two weeks, administered as a subcutaneous injection.
Postmenopausal women with osteoporosis at a high risk of fracture or have a history of osteoporatic fracture, have a new treatment in Tymlos from Radius Health. Tymols was approved in April and is a human parathyroid hormone related peptide analog. Patients should receive supplemental calcium and vitamin D if dietary intake is inadequate. It is not recommended taking Tymlos and parathyroid hormone analogs for more than two years during a patient’s lifetime.
Austedo from Teva Pharmaceuticals was approved in April for the treatment of chorea associated with Huntington’s disease. Dosage is determined individually for each patient based on the reduction of chorea and their tolerability. Austedo is supplied in pill form and must be swallowed whole and must be taken with food.
For those suffering from tardive dyskinesia, Ingrezza from Neurocrine Biosciences was approved in April. Targive dyskinesia is a chronic disorder of the nervous system characterized by involuntary jerky movements of the face, tongue, jaws, trunk, and limbs, usually developing as a late side effect of prolonged treatment with antipsychotic drugs.
Radicava from Mitsubishi Tanabe Pharma was approved in May for the treatment of amyotrophic lateral sclerosis (ALS). This incurable disease is the progressive degeneration of motor neurons in the brain stem and spinal cord leads to atrophy and eventually complete paralysis of the voluntary muscles.
Alunbrig from Ariad Pharmaceutical was approved in April for the treatment of advanced ALK-positive metastatic non-small cell lung cancer.
Alunbrig is specifically indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on, or are intolerant to, the anti-cancer drug, crizotinib.
For those patients with advanced or metastatic urothelial carcinoma, Imfinzi from AstraZeneca was approved in May. The urothelium is a type of thin tissue that lines much of the urinary tract including the renal pelvis, the ureters, the bladder, and parts of the urethra.
Imfinzi is specifically indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who:

  • have disease progression during or following platinum-containing chemotherapy.
  • have disease progression within 12 months of the first treatment or adjuvant treatment with platinum-containing chemotherapy

As with any medication, there are side-effects. Consult with your doctor about these new treatments to see if they are right for you. Talk to your pharmacist to make sure any new drug that you take does not interfere with your current medications.

Final drug approvals from 2016

,

The FDA has approved a few more new medications to close out 2016.
Spinraza was just recently approved to treat children and adults with spinal muscular atrophy (SMA), a rare and often fatal genetic disease affecting muscle strength and movement. Spinraza is an injection administered into the fluid surrounding the spinal cord.

“There has been a long-standing need for a treatment for spinal muscular atrophy, the most common genetic cause of death in infants, and a disease that can affect people at any stage of life,” said Billy Dunn, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “We worked hard to review this application quickly; we could not be more pleased to have the first approved treatment for this debilitating disease.”
SMA is a hereditary disease that causes weakness and muscle wasting because of the loss of lower motor neurons controlling movement. There is wide variability in age of onset, symptoms and rate of progression. Spinraza is approved for use across the range of spinal muscular atrophy patients.
Rubraca was also approved in December to treat women with a advanced ovarian cancer who have been treated with two or more chemotherapies and whose tumors have a specific gene mutation (deleterious BRCA) as identified by an FDA-approved companion diagnostic test.
“Today’s approval is another example of the trend we are seeing in developing targeted agents to treat cancers caused by specific mutations in a patient’s genes,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research and acting director of the FDA’s Oncology Center of Excellence.
“Women with these gene abnormalities who have tried at least two chemotherapy treatments for their ovarian cancer now have an additional treatment option.”
The National Cancer Institute estimates that 22,280 women will be diagnosed with ovarian cancer in 2016 and an estimated 14,240 will die of this disease. Approximately 15 to 20 percent of patients with ovarian cancer have a BRCA gene mutation.
For patients two years of age and older with mild to moderate eczema, Eucrisa was approved. Atopic dermatitis, a chronic inflammatory skin disease, is often referred to as “eczema,” which is a general term for the several types of inflammation of the skin. Atopic dermatitis is the most common of the many types of eczema and onset typically begins in childhood and can last through adulthood. The cause of atopic dermatitis is a combination of genetic, immune and environmental factors. In atopic dermatitis, the skin develops red, scaly and crusted bumps, which are extremely itchy. Scratching leads to swelling, cracking, “weeping” clear fluid, and finally, coarsening and thickening of the skin.
“Today’s approval provides another treatment option for patients dealing with mild to moderate atopic dermatitis,” said Amy Egan, deputy director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research (CDER).
Serious side effects of Eucrisa include hypersensitivity reactions. Eucrisa should not be used in patients who have had a hypersensitivity reaction to Eucrisa’s active ingredient, crisaborole. The most common side effect of Eucrisa is application site pain, including burning or stinging.
Zinplava was approved in October to reduce the recurrence of Clostridium difficile infection (CDI) in patients aged 18 and older. Zinplava is used together with antibacterial drugs that are given to treat CDI. Clostridium difficile causes inflammation of the colon and diarrhea, which can be deadly. Zinplava is administered intravenously by healthcare professionals.
Adverse effects associated with the use of Zinplava may include, but are not limited to, the following:

  • nausea
  • pyrexia
  • Headache

In addition, heart failure was reported more commonly in Zinplava-treated patients with a history of congestive heart failure (CHF) in the two Phase III clinical trials. In patients with a history of CHF, Zinplava should be reserved for use when the benefit outweighs the risk.
The treatment of soft tissue sarcoma just got some help with the approval of Lartruvo with doxorubicin to treat adults with certain types of soft tissue sarcoma (STS), which are cancers that develop in muscles, fat, tendons or other soft tissues. Lartruvo is approved for use with the FDA-approved chemotherapy drug doxorubicin for the treatment of patients with STS who cannot be cured with radiation or surgery and who have a type of STS for which an anthracycline (chemotherapy) is an appropriate treatment.
“For these patients, Lartruvo, added to doxorubicin, provides a new treatment option,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research and acting director of the FDA’s Oncology Center of Excellence. “This is the first new therapy approved by the FDA for the initial treatment of soft tissue sarcoma since doxorubicin’s approval more than 40 years ago.”
And finally, Exondys 51 was just approved to treat patients with Duchenne muscular dystrophy. This is the first drug approved to treat patients with Duchenne muscular dystrophy (DMD). Exondys 51 is specifically indicated for patients who have a confirmed mutation of the dystrophin gene amenable to exon 51 skipping, which affects about 13 percent of the population with DMD.
“Patients with a particular type of Duchenne muscular dystrophy will now have access to an approved treatment for this rare and devastating disease,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “In rare diseases, new drug development is especially challenging due to the small numbers of people affected by each disease and the lack of medical understanding of many disorders. Accelerated approval makes this drug available to patients based on initial data, but we eagerly await learning more about the efficacy of this drug through a confirmatory clinical trial that the company must conduct after approval.”
DMD is a rare genetic disorder characterized by progressive muscle deterioration and weakness. It is the most common type of muscular dystrophy. DMD is caused by an absence of dystrophin, a protein that helps keep muscle cells intact.The first symptoms are usually seen between three and five years of age, and worsen over time. The disease often occurs in people without a known family history of the condition and primarily affects boys, but in rare cases it can affect girls. DMD occurs in about one out of every 3,600 male infants worldwide.
People with DMD progressively lose the ability to perform activities independently and often require use of a wheelchair by their early teens. As the disease progresses, life-threatening heart and respiratory conditions can occur. Patients typically succumb to the disease in their 20s or 30s; however, disease severity and life expectancy vary.
 
Source: FDA
 

Recent FDA Drug Approvals

Dozens of new drugs were approved by the FDA over the past few months of this year. Ranging from cardiovascular medication to skin cancer treatment to type II diabetes treatment and new treatment for cystic fibrosis, read the information below to see if any of these new treatments may provide you some relief.
For cardiovasular patient, Repatha (evolocumab) by Amgen was approved in August for the treatment of high cholesterol. Additionally, Praluent (alirocumab) by Sanofi Aventis, was approved in July for the treatment of cardiovascular disease in people who require additional lowering of LDL cholesterol.
Corlanor (ivabradine), also by Amgen  and Entresto (sacubitril and valsartan) by Novartis were both recently approved for the treatment of chronic heart failure.
Patients suffering from skin cancer now have a new treatment. Odomzo (sonidegib) by Novartis was approved for the treatment of locally advanced basal cell carcinoma. Odomzo is specifically indicated for the treatment of adult patients with locally advanced basal cell carcinoma that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy.
Premenopausal women with generalized hypoactive sexual desire disorder now have a new treatment; Addyi (flibanserin) by Sprout Pharmaceuticals was approved in August.
Synjardy (empagliflozin and metformin hydrochloride) by Boehringer Ingelheim was also approved in August for the treatment of type II diabetes.
There is new hope for chemotherapy patients. Varubi (rolapitant) by Tesaro was approved just this month for the prevention of delayed nausea and vomiting associated with chemotherapy.
Kidney transplant patients may have a new treatment for the prevention of organ rejection. Envarsus XR (tacrolimus extended-release) by Veloxis was approved in July and may provide hope for more successful transplant surgery.
Rexulti (brexpiprazole) by Otsuka as approved in July for the treatment of depression and schizophrenia.
Orkambi (lumacaftor and ivacaftor) by Vertex Pharmaceuticals was approved in July for the treatment of cystic fibrosis in patients 12 and older.
Some patients with chronic obstructive pulmonary disease (COPD) can now take Stiolto Respimat (tiotropium bromide and olodaterol). Producted by Boehringer Ingelheim, and approved in May by the FDA, Stiolto Respimat is specifically indicated for the long-term, once-daily maintenance treatment of airflow obstruction in patients with COPD.
As more drugs are approved, we’ll keep you up-to-date. If you have questions about any of these medications, ask one of our pharmacists for more information and ask your doctor if it is right for you.

pablo (48)

Expiring drug patents and what it means to you

The average life-span of a drug patent is 20 years, but in most cases about half of that time is spent in testing to get the product to the marketplace. That’s because it can take up to eight years for the company get approval from the U.S. Food and Drug Administration (FDA) due to testing, studies and experiments to document the side effects and how effective the drug is on human patients.

Once the patented drug expires, companies can start developing a generic option for the name-brand. In turn, the name-brand sales typically drop by 80% as consumers opt for the less expensive version of the same drug. But is it the same?

The process for developing a generic option for a drug comes with much scrutiny. The companies must produce a drug with the identical makeup of the original drug, and pass the same manufacturing and packaging standards. But before all of that:

  • The original patent must be expired.
  • The original manufacturer must certify that the patents have not been infringed upon, are invalid, or otherwise unenforceable.
  • There have never been any previous patents on the drug or in countries where the drug has no protection by law.

So what’s the difference between the name-brand and the generic version? Cost. Generics have saved Americans $1.67 trillion over the last decade. Generic drugs cost less because the development and marketing costs were built into the cost of the name-brand. Due to trademark laws, generics cannot look or taste exactly like the name brand, but the active ingredients must be the same, ensuring they both have the same medicinal effects.

The following name-brand drugs patents are scheduled to expire this year:

Symlin – Used with insulin, can help control blood sugar in people with diabetes. It’s always used with insulin.

Tecfidera – a fumaric acid ester used to treat relapsing forms of multiple sclerosis (MS).

Flector – can be used as a topical pain reliever for the treatment of acute pain due to minor strains, sprains and contusions.

Cetrotide – can prevent premature ovulation in women undergoing fertility treatments with controlled ovulation.

Omtryg – is used together with diet and exercise to help lower triglyceride levels in the blood.

Bevespi Aerosphere – works to help open airways and keep them open for patients with COPD.

Otovel  – is used to treat a type of middle ear infection in children called acute otitis media with tympanostomy tubes (AOMT) caused by certain bacteria.

Byvalson (Nebivolol & Valsartan) – is a combination medicine used to treat high blood pressure (hypertension) in adults.

Rescriptor – can treat HIV, the infection that causes AIDS. It doesn’t cure HIV or AIDS, but combinations of drugs that treat HIV infection may slow the disease progress and prolong life.

Natroba – a topical suspension is used to treat head lice in adults and children who are at least 6 months old.

Kovanaze – is a nasal spray used as dental anesthesia.

Firazyr – for the treatment of sudden attacks of hereditary angioedema (HAE).

Noxafil – can treat or prevent fungal infections, especially in people with weak immune systems.

Cardiotec –  is used for nutritional support and dietary supplementation.

Troxyca ER – is an extended release capsule formulation of oxycodone combined with naltrexone.

Yosprala – a prescription medicine used in people who have had heart problems or strokes caused by blood clots, to help reduce their risk of further heart problems or strokes, and who are at risk of developing stomach ulcers with aspirin.

Cystaran – can prevent the buildup of cystine crystals in the kidneys in its oral form. Other forms can treat cystine crystal buildup in the eye (cystinosis).

Lumason (sulfur hexafluoride lipid-type A microspheres) – is an ultrasound contrast agent indicated for use in echocardiography to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border in adult patients with suboptimal echocardiograms, and in ultrasonography of the liver for characterization of focal liver lesions in adult and pediatric patients.

Synribo – is used for the treatment of adult patients with chronic or accelerated phase chronic myeloid leukemia.

Ionsys – is used to treat severe pain.

Brimonidine and brinzolamide ophthalmic – can reduce the amount of fluid in the eye, which decreases pressure inside the eye.

Durezol – can treat eye irritation and inflammation.

Ask one of our pharmacists if your prescription is available as a generic.

Sources: Association for Accessible Medicines, Upcouncil, RxSaver, U.S. FDA

fda-approved1

New FDA Approvals

, ,

Several new drugs have been approved since April of this year including treatments for migraine, liver disease, kidney disease, and those facing opioid withdrawal symptoms.

Aimovig (erenumab-aooe) from Amgen has been approved for the preventive treatment of episodic or chronic migraine in adults. Aimovig is supplied as an injection with a recommended dosage of 70 mg once per month. Some patients may benefit from two injections of 70 mg once per month. If a dose of Aimovig is missed, another dose should be administered as soon as possible.

Adverse reactions associated with the use of Aimovig may include, but are not limited to, the following:

  • injection site reactions
  • constipation

For those with a rare, inherited, disorder known as X-linked hypophosphatemia (XLH) Crysvita (burosumab-twza) from Ultragenyx has recently been approved.

XLH is characterized by low levels of phosphate in the blood. Phosphate levels are low because phosphate is abnormally processed in the kidneys, which causes a loss of phosphate in the urine and leads to soft, weak bones (rickets).This genetic disorder affects about one in 20,000 people and is typically, it is passed from one generation to the next, but sometimes appears in an individual with no family history of XLH.

Crysvita is specifically indicated for the treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients one year of age and older and is supplied as an injection every two to four weeks depending on the age of the patient and the length of treatment.

Side effect may include, but are not limited to:

Pediatrics:

  • headache
  • injection site reaction
  • vomiting
  • pyrexia
  • pain in extremity
  • vitamin D decreased

Adults:

  • back pain
  • headache
  • tooth infection
  • restless leg syndrome
  • vitamin D decreased
  • dizziness
  • constipation
  • blood phosphorus increased

AndexXa (coagulation factor Xa (recombinant), inactivated-zhzo) by Portola Pharmaceuticals has recently been approved for the reversal of factor Xa inhibitors. AndexXa is administered via intravenous injection.

This is the first and only antidote indicated for patients treated with drugs such as rivaroxaban and apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. Factor Xa inhibitors are anticoagulants used to prevent deep vein thrombosis and pulmonary embolism in patients undergoing hip or knee replacement surgery.

Side effects include:

  • urinary tract infections
  • pneumonia

Two new drugs have been approved for the treatment of thrombocytopenia (low blood platelet count).

Doptelet (avatrombopag) from AkaRx has been approved for the treatment of thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a procedure that would typically require platelet transfusion. Doptelet is supplied as a tablet for oral administration with dosing beginning 10-13 days prior to the scheduled procedure.

Side effects may include, but are not limited to:

  • pyrexia
  • abdominal pain
  • nausea
  • headache
  • fatigue
  • edema peripheral

Tavalisse (fostamatinib disodium hexahydrate) from Rigel Pharmaceuticals has been approved for the treatment of chronic immune thrombocytopenia (ITP) in adult patients who have had an insufficient response to a previous treatment.

Tavalisse (fostamatinib disodium hexahydrate) is a tyrosine kinase inhibitor with demonstrated activity against spleen tyrosine kinase (SYK).

Tavalisse is supplied as a tablet for oral administration with an initial dose of 100 mg taken orally twice daily for a month. Depending on platelet county, dosage may be increased. Tavalise may be taken with or without food.

Side effects may include:

  • diarrhea
  • hypertension
  • nausea
  • respiratory infection
  • dizziness
  • ALT/AST increased, rash
  • abdominal pain
  • fatigue
  • chest pain
  • neutropenia

For those with higher than normal potassium levels—known as hyperkalemia—Lokelma (sodium zirconium cyclosilicate) from AstraZeneca has been approved. Lokelma is a highly-selective, oral potassium-removing agent.

Lokelma is administered orally as a suspension in water for oral administration. The recommended dose is 10 g administered three times a day for up to 48 hours. For continued treatment, the recommended dose is 10 g once daily. The most common adverse reaction associated with the use of Lokelma is mild to moderate edema.

Palynziq (pegvaliase-pqpz) from BioMarin has been approved for the treatment of phenylketonuria. Phenylketonuria (commonly known as PKU) is an inherited disorder that increases the levels of a substance called phenylalanine in the blood. Phenylalanine is a building block of proteins (an amino acid) that is obtained through the diet. It is found in all proteins and in some artificial sweeteners.Without treatment, phenylalanine builds up in the blood and causes health problems.

Playnziq is specifically indicated to reduce blood phenylalanine concentrations in adult patients with phenylketonuria who have uncontrolled blood phenylalanine concentrations greater than 600 micromol/L on existing management.

Side effects of Palynziq may include:

  • injection site reactions
  • arthralgia
  • hypersensitivity reactions
  • headache
  • generalized skin reactions lasting at least 14 days
  • pruritus
  • nausea
  • abdominal pain
  • oropharyngeal pain
  • vomiting
  • cough
  • diarrhea
  • fatigue

Jynarque (tolvaptan) by Otsuka America has been approved for the treatment of autosomal dominant polycystic kidney disease (PKD). PKD is a genetic disorder characterized by the growth of numerous cysts filled with fluid in both kidneys. The progressive expansion of PKD cysts slowly replaces much of the normal mass of the kidneys, and can reduce kidney function and lead to kidney failure.

Jynarque is a selective vasopressin V2-receptor antagonist that is specifically indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease.

Jynarque is supplied as a tablet for oral administration. The recommended initial dose is 60 mg orally per day as 45 mg taken on waking and 15 mg taken 8 hours later. Titrate to 60 mg plus 30 mg then to 90 mg plus 30 mg per day if tolerated with at least weekly intervals between titrations. Patients may down-titrate based on tolerability.

Adverse effects associated with the use of Jynarque may include, but are not limited to:

  • thirst
  • polyuria
  • nocturia
  • pollakiuria
  • polydipsia

Jynarque (tolvaptan) is not without risk and can cause serious and potentially fatal liver injury. Acute liver failure requiring liver transplantation has been reported.

Lucemyra(lofexidine) by US Worldmeds has been approved for the mitigation of opioid symptoms to facilitate abrupt opioid discontinuation in adults.

Lucemyra is supplied as a tablet for oral administration. The usual starting dosage is three 0.18 mg tablets taken orally 4 times daily during the period of peak withdrawal symptoms (generally the first 5 to 7 days following last use of opioid) with dosing guided by symptoms and side effects. There should be 5 to 6 hours between each dose. The total daily dosage of Lucemyra should not exceed 2.88 mg (16 tablets) and no single dose should exceed 0.72 mg (4 tablets).

Lucemyra treatment may be continued for up to 14 days with dosing guided by symptoms.  Discontinue Lucemyra with a gradual dose reduction over a 2- to 4-day period to mitigate Lucemyra withdrawal symptoms.

Adverse effects associated with the use of Lucemyra may include, but are not limited to:

  • orthostatic hypotension
  • bradycardia
  • hypotension
  • dizziness
  • somnolence
  • sedation
  • dry mouth

Lucemyra may cause low blood pressure or slower heart rate and should be used with caution in patients diagnosed with low blood pressure, slow heart rate, any other cardiac abnormality (including prior diagnosis or family history of long QT syndrome), or prior heart attack.

 

fda-approved1

New FDA Approvals

,

A few new drugs have been approved by the FDA so far this year. Among them are treatments for cystic fibrosis, prostate cancer, pancreatic cancer, and two new treatments for HIV.
Symdeko from Vertex is a combination of tezacaftor and ivacaftor for the treatment of cystic fibrosis in patients age 12 years and older. Tezacaftor is a cystic fibrosis transmembrane conductance regulator (CFTR) corrector. Ivacaftor is a CFTR potentiator.
Symdeko is specifically indicated for the treatment of patients with cystic fibrosis (CF) aged 12 years and older who are homozygous for the F508del mutation or who have at least one mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to tezacaftor/ivacaftor based on in vitro data and/or clinical evidence.
The recommended dose of Symdeko is one tablet (tezacaftor 100 mg/ivacaftor 150 mg) taken in the morning and one tablet (ivacaftor 150 mg) taken in the evening, approximately 12 hours apart. The tablets should be swallowed whole. Symdeko should be taken with fat-containing food.
Adverse effects associated with the use of Symdeko may include, but are not limited to:

  • headache
  • nausea
  • sinus congestion
  • dizziness

Erleada from Janssen Oncology was approved in February to treat a certain type of prostate cancer using novel clinical trial endpoint.  Erleada works by blocking the effect of androgens, a type of hormone, on the tumor. These androgens, such as testosterone, can promote tumor growth.
“The FDA evaluates a variety of methods that measure a drug’s effect, called endpoints, in the approval of oncology drugs. This approval is the first to use the endpoint of metastasis-free survival, measuring the length of time that tumors did not spread to other parts of the body or that death occurred after starting treatment,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “In the trial supporting approval, Erleada had a robust effect on this endpoint. This demonstrates the agency’s commitment to using novel endpoints to expedite important therapies to the American public.”
Adverse effects associated with the use of Erleada may include:

  • fatigue
  • hypertension
  • rash
  • diarrhea
  • nausea
  • weight decreased
  • arthralgia
  • fall
  • hot flush
  • decreased appetite
  • fracture
  • peripheral edema

Advanced Accelerator Applications has recently received FDA approval for Lutathera to treat a type of cancer that affects the pancreas or gastrointestinal tract called gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Lutathera (lutetium Lu 177 dotatate) is a radiolabeled somatostatin analog.

Lutathera is supplied as an injection for intravenous administration. The recommended dose is 7.4 GBq (200 mCi) every 8 weeks for a total of 4 doses.
Adverse effects may include, but are not limited to, the following:

  • lymphopenia
  • increased GGT
  • vomiting
  • nausea
  • increased AST
  • increased ALT
  • hyperglycemia
  • hypokalemia

Biktarvy from Gilead was approved in February for the treatment of HIV-1 infection in adults.
Biktarvy is specifically indicated as a complete regimen for the treatment of HIV-1 infection in adults who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 c/mL) on a stable antiretroviral regimen for at least three months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Biktarvy.
Biktarvy is supplied as a tablet for oral administration. The recommended dose is one tablet once daily with or without food.
Adverse events associated with the use of Biktarvy may include:

  • diarrhea
  • nausea
  • headache

TaiMed Biologics has received FDA approval for Trogarzo to treat HIV patients who have tried multiple HIV medications in the past and whose HIV infections cannot be successfully treated with other currently available therapies (multidrug resistant HIV, or MDR HIV). This antiretroviral medication is administered once every 14 days and used in combination with other limited antiretroviral medications.
“While most patients living with HIV can be successfully treated using a combination of two or more antiretroviral drugs, a small percentage of patients who have taken many HIV drugs in the past have multidrug resistant HIV, limiting their treatment options and putting them at a high risk of HIV-related complications and progression to death,” said Jeff Murray, M.D., deputy director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research. “Trogarzo is the first drug in a new class of antiretroviral medications that can provide significant benefit to patients who have run out of HIV treatment options. New treatment options may be able to improve their outcomes.”
Adverse effects associated with the use of Trogarzo may include:

  • diarrhea
  • dizziness
  • nausea
  • rash

 

New FDA Approvals for First Quarter of 2017

The FDA approved several new drugs in the first quarter of 2017.
For patients 12 years and older who have Merkel cell carcinoma, Bavencio (avelumab) from Merck was recently approved by the FDA). Side effects may include:

  • fatigue
  • musculoskeletal pain
  • diarrhea
  • nausea
  • infusion-related reaction
  • rash
  • decreased appetite
  • peripheral edema

Dupixent (dupilumab) was approved for the treatment of adults with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Side effects may include:

  • injection site reactions
  • conjunctivitis (pink eye)
  • blepharitis (inflammation of the eyelid)
  • oral herpes
  • keratitis (inflammation of the cornea)
  • eye pruritus (severe itching)
  • other herpes simplex virus infection
  • dry eye

Rhofade (oxymetazoline hydrochloride) is a new topical cream for the treatment of persistent facial erythema (flushing) associated with rosacea in adults. Side effects may include:

  • application site dermatitis
  • worsening inflammatory lesions of rosacea
  • application site pruritis (itchy skin)
  • application site erythema (reddening of the skin)
  • application site pain

For adult patients suffering from plaque psoriasis who are are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies, Siliq (brodalumab) is a new treatment. Like other medications, adverse effects may include:

  • joint pain
  • headache
  • fatigue
  • diarrhea
  • throat pain
  • nausea
  • muscle pain
  • injection site reactions
  • influenza
  • neutropenia
  • tinea infections

For the treatment of secondary hyperparathyroidism in adults with chronic kidney disease on hemodialysis, Parsabiv (etelcalcetide) was approved in February by the FDA. Side effects could include:

  • decreased blood calcium
  • muscle spasms
  • diarrhea
  • nausea
  • vomiting
  • headache
  • hypocalcemia (calcium deficiency disease)
  • paresthesia (burning or prickling sensation)

Qtern (dapagliflozin and saxagliptin) was recently approved for the treatment of inadequately controlled type II diabetes. Specifically indicated to work alongside diet and exercise, Qtern was approved to improve glycemic control in adults with type 2 diabetes mellitus (T2DM) who have inadequate control with dapagliflozin or who are already treated with dapagliflozin and saxagliptin.
Side effects could include:

  • upper respiratory tract infection
  • urinary tract infection
  • elevated cholesterol

Those suffering from constipation, two new treatments are available:
For those with opioid-induced constipation, Symproic (naldemedine) is now available. Side effects can include:

  • abdominal pain
  • diarrhea
  • nausea

For adults with chronic idiopathic constipation, Trulance (plecanatide) is now available. The most common side effect is diarrhea.

Xermelo (telotristat ethyl) is specifically indicated for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy.
Adverse effects associated with the use of Xermelo may include, but are not limited to, the following:

  • nausea
  • headache
  • increased GGT
  • depression
  • flatulence
  • decreased appetite
  • peripheral edema
  • pyrexia

For patients with relapsing or primary progressive forms of multiple sclerosis, Ocrevus (ocrelizumab). Side effects may include:

  • upper respiratory tract infections
  • infusion reaction

Emflaza (deflazacort) is a corticosteroid which exerts anti-inflammatory and immunosuppressive effects in patients 5 years of age and older. Side effects may include:

  • cushingoid appearance
  • weight increased
  • increased appetite
  • upper respiratory tract infection
  • cough
  • frequent urination
  • male patterned hair growth in women
  • central obesity
  • nasopharyngitis

Parsabiv (etelcalcetide) was recently approved for the treatment of secondary hyperparathyroidism in adults with chronic kidney disease on hemodialysis. Side effects can include:

  • blood calcium decreased
  • muscle spasms
  • diarrhea
  • nausea
  • vomiting
  • headache
  • hypocalcemia (low calcium)
  • paresthesia (burning or prickling sensation)

Those suffering from Parkinson’s have a new treatment option. Approved in March of this year, Xadago (safinamide) may include side effects such as:

  • dyskinesia (abnormal involuntary movements)
  • fall
  • nausea
  • insomnia

A new endocrine-based therapy has just been approved for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)- negative advanced or metastatic breast cancer. Kisqali (ribociclib) is specifically indicated in combination with an aromatase inhibitor as initial as initial endocrine-based therapy.

  • Neutropenia (low white blood cell count)
  • nausea
  • fatigue
  • diarrhea
  • leukopenia
  • alopecia
  • vomiting
  • constipation
  • headache
  • back pain

Zejula (niraparib) is specifically indicated for the maintenance treatment of adults with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Numerous side effects include (but not limited to):

  • insomnia
  • anemia
  • nausea
  • constipation
  • vomiting
  • diarrhea
  • dry mouth
  • fatigue
  • anxiety
  • decreased appetite
  • Hypertension

Talk to your doctor about these medications to see if they may be right for you. Often times the results of taking a new medication outweigh the risks. And talk to your pharmacist to check for any potential complications with taking these along with other medications that you are currently taking.

New FDA Approvals

,

New medications have recently been approved by the FDA for cardiovascular patients, diabetes, muscular dystrophy, and seizures — to name a few.
Yospral from Aralez Pharmaceuticals is a combination of aspirin, an anti-platelet agent, and omeprazole, a proton pump inhibitor (PPI), for patients who require aspirin for secondary prevention of cardiovascular and cerebrovascular events and who are at risk of developing aspirin associated gastric ulcers.
Zinplava from Merck is indicated to reduce recurrent Clostridium Difficile Infection (CDI) in patients receiving antibacterial treatment for CDI. Zinplava is not an antibiotic and is not indicated for treatment of CDI. It should only be used in conjunction with antibacterial drug treatment of CDI.
Adlyxin from Sanofi Aventis will help adults with type II diabetes by increasing glucose-dependent insulin release, and decreasing glucagon secretion. It will also slow gastric emptying. Adlyxin is to be used in conjunction with a healthy diet and exercise.
For patients with AIDS who also suffer from anorexia, Syndos from Insys Therapeutics is now available. Syndos is also approved for nausea and vomiting associated with chemotherapy in cancer patients who have failed to respond well to other anti-nausea treatments.
Another new drug was approved for the prevention of chemotherapy-induced nausea and vomiting. Sustol from Heron Therapeutics is an extended release injection specifically indicated for use in combination with other anti-nausea treatments in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens.
Patients with a Duchenne muscular dystrophy with mutated DMD gene amenable to exon 51 skipping may have a new option in Exondys 51 from Sarepta. This new medication was granted accelerated approval based on an observed increase in dystrophin in skeletal muscle in some patients. A clinical trial of this new medication has not been established and continued approval may be contingent of a confirmed clinical benefit in a trial.
Carnexiv from Lundbeck is a replacement therapy for oral carbamazepine when oral administration is not feasible, in adults with seizures. Carnevix is supplied as an injection for intravenous administration.
Troxyca ER from Pfizer is new on the market for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment. Troyxca ER is an extended release capsule formulation of oxycodone combined with naltrexone. Oxycodone is a full opioid agonist and naltrexone is an opioid antagonist.
Two new drugs are now available for the treatment of certain cancers.
Keytruda from Merck has been approved for the treatment of head and neck squamous cell cancer. Keytruda is a programmed death receptor-1 (PD-1)-blocking antibody specifically indicated for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy.
Lartruvo from Eli Lilly has been approved for the treatment of soft tissue sarcoma. Lartruvo is specifically indicated for use in combination with doxorubicin, for the treatment of adult patients with soft tissue sarcoma (STS) with a histologic subtype for which an anthracycline-containing regimen is appropriate and which is not amenable to curative treatment with radiotherapy or surgery.
Talk to your doctor about your specific condition and if any of these medications are right for you. Like most medications, all come with a list of potential side-effects.
Sources: FDA and Centerwatch

New FDA approvals in the second quarter of 2016

Several new medications were approved in the second quarter of 2016 for certain cancers, hypertension, Parkinson’s disease, and COPD.
Byvalson was just approved in June for the treatment of hypertension to lower blood pressure. The positive effects of this oral medication are normally seen within the first two to four weeks of taking it.
Adverse effects may include:

  • skull hypoplasia
  • Anuria
  • Hypotension
  • renal failure
  • death

Those diagnosed with plaque psoriasis have an new treatment option in Taltz.
Taltz is administered by injection and is specifically indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
Adverse effects may include:

  • injection site reactions
  • upper respiratory tract infections
  • nausea
  • tinea infections

Serious infections have occurred with the use of Taltz. If signs or symptoms of clinically important chronic or acute infection occur, or if a serious infection develops, discontinue Taltz until the infection resolves.
Opdivo was approved in May and targets the cellular pathway known as PD-1/PD-L1, proteins found on the body’s immune cells and some cancer cells. By blocking this pathway, Opdivo may help the body’s immune system fight cancer cells.
Opdivo is specifically indicated for the treatment of patients with classical Hodgkin lymphoma that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and post-transplantation brentuximab vedotin.
Adverse effects may include:

  • fatigue
  • upper respiratory tract infection
  • cough
  • pyrexia
  • diarrhea
  • rash
  • pruritus
  • musculoskeletal pain
  • nausea
  • vomiting
  • abdominal pain
  • headache
  • peripheral neuropathy
  • arthralgia
  • dyspnea
  • infusion-related reactions
  • hypothyroidism or thyroiditis

Venclexta was approved in April for the treatment of patients with chronic lymphocytic leukemia (CLL) with 17p deletion, as detected by an FDA approved test, who have received at least one prior therapy. The tablet should be taken orally once per day with a meal and water.
Adverse effects may include:

  • neutropenia
  • diarrhea
  • nausea
  • anemia
  • upper respiratory tract infection
  • thrombocytopenia
  • fatigue

Those suffering from renal cell car carcinoma and who have received prior antiangiogenic therapy have a new treatment. Cabometyx is supplied as tablets for oral administration and patients should not to eat for at least 2 hours before and at least 1 hour after taking Cabometyx. Do not substitute Cabometyx tablets with cabozantinib capsules.
Adverse effects may include

  • diarrhea
  • fatigue
  • nausea
  • decreased appetite
  • palmar-plantar erythrodysesthesia syndrome
  • hypertension
  • vomiting
  • weight decreased
  • constipation

Lenvima was approved in May for the treatment of advanced renal cell carcinoma. Lenvima is specifically indicated for use in combination with everolimus for the treatment of patients with advanced RCC following one prior anti-angiogenic therapy. Lenvima is supplied as a capsule for oral administration once daily with or without food, and in combination with 5 mg everolimus. 
Adverse effects associated with the use of  Lenvima + everolimus may include:

  • diarrhea
  • fatigue
  • arthralgia/myalgia
  • decreased appetite
  • vomiting
  • nausea
  • stomatitis/oral inflammation
  • hypertension
  • peripheral edema
  • cough
  • abdominal pain
  • dyspnea
  • rash
  • weight decreased
  • hemorrhagic events
  • proteinuria

Nuplazid was approved in May for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis. Nuplazid is supplied as a tablet for oral administration and can be taken with or without food.
Adverse effects may include:

  • peripheral edema
  • confusional state

Nuplazid comes with the following Black Box warning: Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Nuplazid is not approved for the treatment of patients with dementia-related psychosis unrelated to the hallucinations and delusions associated with Parkinson’s disease psychosis.

Those suffering from COPD have a new treatment option. Bevespi Aerosphere is specifically indicated for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
Bevespi Aerosphere is supplied as an aerosol for oral inhalation. The recommended dose for the maintenance treatment of COPD is two inhalations twice daily in the morning and in the evening. Two inhalations equal one dose.
Adverse effects may include:

  • urinary tract infection
  • cough

Bevespi Aerosphere comes with the following Black Box warning: Long-acting beta2-adrenergic agonists (LABAs), such as formoterol fumarate, one of the active ingredients in Bevespi Aerosphere, increase the risk of asthma-related death. The safety and efficacy of Bevespi Aerosphere in patients with asthma have not been established. Bevespi Aerosphere is not indicated for the treatment of asthma.
Talk to you doctor to see if any of these new medications are right for you. Also ask your pharmacist about any potential negative drug interactions before beginning new medications.
 
Source: Center Watch
 

Load More

Translate »