April 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