Updates from FDA
New drugs
COAGULATION FACTOR VIIA (RECOMBINANT)-JNCW
(Sevenfact—Laboratoire Francais du Fractionnement et des Biotechnologies S.A.)
Drug class: Recombinant analog of human FVII
Indication: Treatment and control of bleeding episodes in adults and adolescents ages 12 years and older with hemophilia A or B with inhibitors. Contains an active ingredient expressed in genetically engineered rabbits. Not indicated for treatment of congenital factor VII deficiency.
Recommended dosage: Available as a lyophilized powder in single-use vials containing 1 mg or 5 mg of the product. For mild or moderate bleeds, administer 75 mcg/kg intravenously every 3 hours until hemostasis is achieved; or administer initial dose of 225 mcg/kg, and if hemostasis is not achieved within 9 hours, administer an additional 75 mcg/kg doses every 3 hours as needed to achieve hemostasis.
For severe bleeds, administer 225 mcg/kg, followed if necessary 6 hours later with 75 mcg/kg every 2 hours.
Adverse effects: Headache, dizziness, infusion site discomfort, infusion-related reaction, infusion site hematoma, fever
Contraindications: Patients with known allergy or hypersensitivity to rabbits or rabbit proteins
Boxed warning: Patients with hemophilia A or B with inhibitors who have other risk factors for blood clots may be at increased risk of serious arterial and venous thrombotic events. Hypersensitivity reactions, including anaphylaxis, are possible. Monitor patients for signs or symptoms of activation of the coagulation system and for thrombosis.
SELUMETINIB
(Koselugo—AstraZeneca)
Drug class: Kinase inhibitor
Indication: First FDA-approved drug to treat pediatric patients ages 2 years and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). NF1 is a rare, progressive genetic disorder characterized by changes in skin coloring, neurologic and skeletal impairments, and risk for development of benign and malignant tumors (PN) throughout life that involve the nerve sheaths and can grow anywhere in the body, including the face, extremities, areas around the spine and deep in the body, where they may affect organs.
Recommended dosage: 25 mg/m2 taken orally daily twice daily on an empty stomach; do not consume food 2 hours before or 1 hour after each dose. Dosage should be reduced to 20 mg/m2 orally twice daily in patients with moderate hepatic impairment (Child-Pugh B). The recommended dosage for patients with severe hepatic impairment (Child-Pugh C) has not been established.
Adverse effects: Vomiting, rash, abdominal pain, diarrhea, nausea, dry skin, fatigue, musculoskeletal pain, fever, acne, inflammation of the mouth and lips, headache, paronychia, itching
Warnings and precautions: Can cause serious adverse effects, including heart failure (manifested as ejection fraction decrease) and ocular toxicity, including retinal vein occlusion, retinal pigment epithelial detachment, and impaired vision. Patients should have cardiac and ophthalmic assessments performed prior to initiating selumetinib and at regular intervals during treatment.
Can also cause increased creatinine phosphokinase (CPK). CPK elevation should prompt an evaluation for rhabdomyolysis, and the drug should be withheld, and the dosage reduced or permanently discontinued based on the severity of adverse reactions. Further, selumetinib contains vitamin E, and patients are at an increased risk of bleeding if their daily intake of vitamin E exceeds the recommended or safe limits.
Findings from animal studies show that selumetinib may cause harm to a newborn baby when administered to a pregnant woman. FDA advises health professionals to tell females of reproductive age, and males with female partners of reproductive potential, to use effective contraception during treatment and for 1 week after the last dose.
First Proventil HFA generic approved
FDA approved albuterol sulfate metered dose inhaler, 90 mcg/inhalation (Cipla Limited), the first generic of Merck’s Proventil HFA, to treat or prevent bronchospasm in patients ages 4 years and older who have reversible obstructive airway disease, as well as to prevent exercise-induced bronchospasm in this age group.
“The FDA recognizes the increased demand for albuterol products during the novel coronavirus pandemic,” said FDA Commissioner Stephen M. Hahn, MD, in a news release. “We remain deeply committed to facilitating access to medical products to help address critical needs of the American public.”
In March 2020, FDA issued a revised draft product-specific guidance for proposed generic albuterol sulfate metered dose inhalers, including drug products referencing Proventil HFA. Among other things, the draft guidance provides bioequivalence recommendations. FDA requires applicants to submit appropriate data and information to demonstrate that complex generic drug-device combination products meet the agency’s rigorous approval standards. These standards ensure quality generic drug products are as safe and effective as their brand name counterparts.
The most common adverse effects of the inhaler are upper respiratory tract infection, rhinitis, nausea, vomiting, rapid heart rate, tremor, and nervousness.