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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.

Managing Head Lice

Though there isn’t really a season for head lice, it usually is associated with kids going back to school. However, oftentimes, kids have lice all summer, but they don’t realize it since they are too busy playing to notice their scalp is itching.

Unlike body lice which is associated with poor hygiene or overcrowding in war-torn countries, head lice do not carry bacteria and they prefer clean, shiny, healthy hair in which to hide.

A few facts about head lice:

  • A louse is an insect with six legs and no wings.
  • They doesn’t hop like fleas and they don’t fly, but can crawl pretty fast.
  • They don’t like light.
  • Head lice is more common in children between ages of 3 and 11.
  • There are between 12 million and 25 million infestations each year.
  • It’s more common in girls than in boys. Girls tend to share brushes and barrettes, play with each other’s hair and have closer contact with each other than boys do.
  • They are extremely contagious and are spread by direct head-to-head physical contact, sharing clothing, such as hats or bedding, and sharing combs or brushes with someone who has head lice.
  • Head lice infest the hair on your head, as well as the eyebrows and eyelashes.
  • Head lice only live on human heads and survive by on its host’s blood.
  • Having head lice does not mean you have poor cleanliness.
  • Head lice do not carry diseases.

Signs and symptoms:

  • Extremely itchy scalp.
  • Small red bumps on the scalp or neck.
  • Tiny white nits on the hair close to the scalp that are difficult to remove.
  • Crawling sensation on the head.

You don’t need to check your child’s head regularly unless he or she is scratching and complains of an itchy scalp. In case of infestation, it is more important to treat the child’s family members because they are at higher risk for getting lice, not so much the child’s classmates.

How to treat head lice:

Head lice are hard to find on the scalp because the minute you put light on them, they take off and are camouflaged in hair. They are also easier to see in bright light or by parting the hair to see close to the scalp. They are easier to see near the ears and the nape of the neck. The best way to look for them is to find the eggs, which measure about .8 of a millimeter. The eggs are attached with special glue to the hair. Once they’re cemented to the hair, they are going to stay there unless they’re pulled out with fingernail, tweezers, a fine comb, or the hair is cut.

If your child does have lice, try an over-the-counter insecticidal (anti-lice) shampoo, but make sure you follow the instructions closely.

Over-the-counter lotions and shampoos that contain pyrethrin—a common synthetic chemical used as an insecticide—or one-percent permethrin are often the first choice. The package directions should be followed exactly. These products may continue to kill lice for two weeks after treatment; many clinicians recommend a second treatment seven to nine days after the first.

Side effects of permethrin may include burning or stinging, itching, red skin, or numbness. Also, using them too often may lead to resistance in head lice, making them immune to the products. Don’t bother nit-picking the scalp after treating with insecticidal shampoo.

If this doesn’t work, your doctor can prescribe stronger products. Prescription-strength five-percent permethrin, malathion lotion, or benzyl alcohol lotion may be needed.There is no clear scientific evidence that lice can be suffocated by home remedies, such as mayonnaise or olive oil, but they may be suffocated by Cetaphil cleanser. Tea tree oil is another helpful natural remedy.

It is very important that the nits are removed. This can be difficult because they cling tightly to the hair. Special nit combs are available at our pharmacy and are usually included in kits such as RID and NIX. You should do a second combing seven to 10 days after the first. Nits may live for two weeks.

It’s also important to wash hats, scarves, coats, and bedding in hot water and dried in a hot dryer for at least 20 minutes. Combs and brushes should be washed and the room of the infected person should be vacuumed. These tips can help prevent another outbreak.

Prevention

Children should be cautioned not to share hats, combs, or brushes with others.Policies vary regarding school attendance for children with head lice. If your child has head lice, talk to your child’s school to let them know so that other parents can be notified in case of contact.

Good News for those with MS!

Multiple Sclerosis (MS) is an autoimmune disease that attacks the myelin sheath, the material that surrounds and protects your nerve cells, affecting your brain and your spinal cord. Approximately 2 million people worldwide have MS.

Autoimmune disorders occur when the immune system malfunctions and attacks the body’s own tissues and organs, in this case tissues of the nervous system.

Multiple sclerosis usually begins in early adulthood, between ages 20 and 40. The symptoms vary widely, and affected individuals can experience one or more effects of nervous system damage.

Common symptoms:

  • Fatigue which can interfere with the ability to function at work or home.
  • Difficulty walking related to weakness, muscle spasms, and loss of balance.
  • Numbness or tingling  of the face, body or limbs.
  • Spasticity or feelings of stiffness and involuntary muscle spasms in arms and legs.
  • Weakness due to nerve damage or deconditioning of unused muscles.
  • Vision problems is often the first symptom and is characterized by blurred vision, poor contrast of color vision, and pain on eye movement.
  • Dizziness and vertigo can make people with MS feel off-balance or lightheaded.
  • Bladder problems occur in 80% or people with MS.
  • Sexual problems are very common among people with MS. Damage to the  central nervous system, plus fatigue, spasticity, and psychological factors can affect sexual responses.
  • Bowel problems including constipation and loss of bowel control are common symptoms.
  • Pain is common in MS and half of patients in one study had chronic pain.
  • Cognitive changes are apparent in more than 50% of people with MS. These changes affect the ability to process information and perceive the environment around you, learn and remember new information, problem solve, and focus.
  • Emotional changes including depression, mood swings, irritability, and episodes of uncontrollable laughing and crying, can be the result of the stress of living with MS, or from neurological changes.
  • Clinical depression, the most severe form of depression, is more common in people with MS than any other group of people, including the general population.

There is not ONE test that diagnoses MS. Oftentimes, your doctor will rule out other diseases before determining the you have MS. Blood tests, MRI, lumbar puncture for spinal fluid, and evoked potential tests, which record the electrical signals produced by your nervous system in response to stimuli, are used diagnose.

Now for the good news:

A few days ago, the FDA approved a new medication that is a first to treat the most common form of MS called relapsing-remitting MS (RRMS), but it also has been approved to treat a rare form of MS. Primary progressive MS (PPMS) is an especially debilitating form of MS where the disease steadily worsens rather than having periods of remission like RRMS.

Ocrevus [Ocrelizumab] from Genentech is a type of drug known as a monoclonal antibody, which targets a specific type of immune cell thought to be involved with nerve and myelin cell damage. Ocrevus was given a “breakthrough therapy designation” last year because of its ability to treat PPMS.

In clinical trials, patients received 600 mg intravenously every 6 months. “An infusion every 6 months makes it very convenient, so people don’t have to take it on a more regular basis like injectables or pills,” said Clyde E. Markowitz, MD, director of the Multiple Sclerosis Center at the University of Pennsylvania and the principal investigator on the primary progressive trial for Ocrelizumab.

In clinical trials:

  • Ocrevus helped to slow the progression of PPMS by 24%. That means that patients who were taking the drug were more stable.
  • In patients with RRMS, there was a 46% decrease in annual relapse rates.Doctors say patients on average relapse once a year without treatment.
  • 48% of patients in the relapsing-remitting MS trial had no relapses, no worsening of neurological symptoms, and no new brain lesions seen on MRI scans.

“The results for the relapsing trial were more impressive, given that they were tested against an already approved therapy, but progressive disease is harder to study because it occurs so slowly,” he says. “To see a significant benefit would take years, and this was only approximately a 2-year trial”, says Markowitz.

According to the FDA, Ocrevus should not be used by patients with hepatitis B or other active infections. It may also increase the chance of cancers, particularly breast cancer.

The annual cost of Ocrevus could range from $60,000 to $70,000 per year before insurance. PPMS patients may have an easier time getting approval from their insurance company since it is the only medication for that form of MS and there are many treatment options for RRMS.

Ocrevus will be available in the US with the next two weeks.

Want to help?

Get involved and help raise awareness and money for Multiple Sclerosis. The MS Walk in Wilmington will be held on May 6, 2017 at Greenfield Lake. For more information, or to sign up, click here.