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:

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:

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