Updates from FDA
New drugs
ABAMETAPIR LOTION
(Xeglyze—Dr. Reddy’s Laboratories)
Drug class: Pediculicide.
Indication: Topical treatment of head lice infestation in patients aged 6 months and older.
Recommended dosage and administration: Apply to dry hair in an amount sufficient (up to the full content of one bottle) to thoroughly coat the hair and scalp. Massage into the scalp and throughout the hair, leave on the hair and scalp for 10 minutes, and then rinse off with warm water. Treatment involves a single application. Discard any unused product. Do not flush content down sink or toilet. For topical use only; not for oral, ophthalmic, or intravaginal use.
Common adverse effects: Erythema, rash, skin burning sensation, contact dermatitis, vomiting, eye irritation, pruritus, and hair color changes.
Warnings and precautions: Risk of neonatal benzyl alcohol toxicity and risk of benzyl alcohol toxicity from accidental ingestion.
Drug interactions: For 2 weeks after application, avoid taking drugs that are substrates of CYP3A4, CYP2B6, or CYP1A2. Otherwise, avoid use of abametapir.
BELANTAMAB MAFODOTIN-BLMF
(Blenrep—GlaxoSmithKline)
Drug class: B-cell maturation antigen (BCMA)–directed antibody and microtubule inhibitor conjugate.
Indication: Treatment of adult patients with relapsed or refractory multiple myeloma who have received at least 4 prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.
Recommended dosage: 2.5 mg/kg as an I.V. infusion over approximately 30 minutes once every 3 weeks.
Common adverse effects: Keratopathy, decreased visual acuity, nausea, blurred vision, pyrexia, infusion-related reactions, and fatigue. Most common grade 3 or 5 laboratory abnormalities are decreased platelets, lymphocytes, hemoglobin, and neutrophils; and increased creatinine and gamma-glutamyl transferase.
Boxed warning: Ocular toxicity. The medication has caused changes in the corneal epithelium resulting in changes in vision, including severe vision loss and corneal ulcer, and symptoms such as blurred vision and dry eyes. Conduct ophthalmic exams at baseline, prior to each dose, and promptly for worsening symptoms. Blenrep is available only through a Risk Evaluation and Mitigation Strategy program.
Other warnings and precautions: Thrombocytopenia, infusion-relation reactions, embryo-fetal toxicity. Advise patients not to breastfeed.
NIFURTIMOX
(Lampit—Bayer)
Drug class: Nitrofuran antiprotozoal.
Indication: Treatment of Chagas disease (American Trypanosomiasis) caused by Trypanosoma cruzi in pediatric patients younger than 18 years and weighing at least 2.5 kg.
Recommended dosage: Total daily dose is 8 to 10 mg/kg for patients 40 kg or greater, and 10 to 20 mg/kg for patients less than 40 kg. Administer tablets orally, three times daily with food for 60 days.
Common adverse effects: Vomiting, abdominal pain, headache, decreased appetite, nausea, pyrexia, and rash.
Warnings and precautions: Potential for genotoxicity and carcinogenicity, embryo-fetal toxicity, worsening neurological and psychiatric conditions, hypersensitivity, decreased appetite and weight loss, porphyria. Patients of reproductive potential should obtain a pregnancy test before treatment. Patients and their partners should use effective contraception during treatment.
Contraindications: Known hypersensitivity to nifurtimox or any excipients and alcohol consumption during treatment.
PRALSETINIB
(Gavreto—Genentech)
Drug class: Kinase inhibitor.
Indication: Treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive non–small cell lung cancer as detected by an FDA-approved test.
Recommended dosage: 400 mg orally once daily on an empty stomach (no food intake for at least 2 hours before and at least 1 hour after taking the medication).
Common adverse effects: Fatigue, constipation, musculoskeletal pain, and hypertension. Most common grade 3 or 4 laboratory abnormalities were decreased lymphocytes, neutrophils, phosphate, hemoglobin, sodium, and calcium; and increased alanine aminotransferase.
Warnings and precautions: Interstitial lung disease/pneumonitis, hypertension, hepatotoxicity, hemorrhagic events, risk of impaired wound healing, embryo-fetal toxicity. Advise patients not to breastfeed during treatment.
Drug interactions: Avoid use with strong CYP3A inhibitors; combined P-gp and strong CYP3A inhibitors (if coadministration can’t be avoided, reduce dose of pralsetinib); and strong CYP3A inducers (if coadministration can’t be avoided, increase dose of pralsetinib).
VILTOLARSEN
(Viltepso—NS Pharma)
Drug class: Antisense oligonucleotide.
Indication: Treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping.
Recommended dosage: Recommended dosage is 80 mg/kg of body weight, once weekly. Administer as an I.V. infusion over 60 minutes. Serum cystatin C, urine dipstick, and urine protein-to-creatinine ration should be measured before starting treatment.
Common adverse effects: Upper respiratory tract infection, injection site reaction, cough, and pyrexia.
Warnings and precautions: Kidney toxicity.
New Formulation
AZACITIDINE, ORAL
(Onureg—Celgene)
Drug class: Nucleoside metabolic inhibitor.
Indication: Continued treatment of adult patients with acute myeloid leukemia who achieved first complete remission or complete remission with incomplete blood count recovery following intensive induction chemotherapy and are not able to complete intensive curative therapy.
Recommended dosage: Administer 300 mg orally once daily on days 1 through 14 of each 28-day cycle. Administer an antiemetic before each dose for at least the first 2 cycles. Do not substitute for I.V. or S.C. azacitidine because the oral formulation’s indications and dosing regimen are different.
Common adverse effects: Nausea, vomiting, diarrhea, fatigue/asthenia, constipation, pneumonia, abdominal pain, arthralgia, decreased appetite, febrile neutropenia, dizziness, and pain in extremity.
Warnings and precautions: Risks of substitution with other azacitidine products, myelosuppression, embryo-fetal toxicity. Contraindicated in patients with history of severe hypersensitivity to azacitidine or its components. Advise patients not to breastfeed.
New acne treatment gains FDA approval
On August 26, FDA approved clascoterone cream 1% (Winlevi—Cassiopea) for the treatment of acne vulgaris in patients 12 years and older. It is the first acne drug with a new mechanism of action approved by the agency in nearly 40 years.
Clascoterone, a first-in-class topical androgen receptor inhibitor, targets androgens, which largely drive sebum production and inflammation, two of the four distinct pathways—the other two are clogged pores and bacteria growth—that affect acne. Until now, the need for topical acne treatment options that tackle androgens have been largely unmet.
To administer the medication, patients should apply a thin layer (approximately 1 g) to affected areas twice daily—once in the morning and once in the evening. Individuals should avoid contact with the eyes, mouth, and mucous membranes. This medication is not for ophthalmic, oral, or vaginal use.
Clascoterone’s prescribing information comes with warnings and precautions for local irritation, including pruritus, burning, skin redness, or peeling; hypothalamic-pituitary-adrenal (HPA) axis suppression; and hyperkalemia. Discontinue use if patients experience HPA axis suppression. Pharmacists should also know that pediatric patients may be more susceptible to systemic toxicity.
The drug’s most common adverse effects are erythema, pruritus, and scaling or dryness. More than 3% of patients also experienced edema, stinging, and burning.
Clascoterone is expected to be available in the United States in early 2021.
FDA OKs new treatment for growth hormone deficiency
On August 28, FDA approved somapacitan-beco (Sogroya—Novo Nordisk) for treatment of adults with growth hormone deficiency. The drug is the first human growth hormone therapy that patients can take subcutaneously only once a week.
Somapacitan-beco comes as a single-patient-use prefilled pen of 10 mg/1.5 mL. Patients should administer the medication through an injection to the abdomen or thigh, regularly rotating injection sites to avoid lipohypertrophy or lipoatrophy.
Providers should initiate treatment with a dosage of 1.5 mg once weekly for treatment-naive patients and those who are switching from daily growth hormone. They can increase the weekly dosage every 2 to 4 weeks by approximately 0.5 mg to 1.5 mg until the patient achieves the desired response. The recommend dosage should not exceed
8 mg once weekly.
Somapacitan-beco comes with warnings and precautions for increased risk of neoplasm; glucose intolerance and diabetes mellitus; intracranial hypertension; hypersensitivity; fluid retention; hypoadrenalism; hypothyroidism; pancreatitis; and lipohypertrophy or lipoatrophy.
Providers should perform an eye exam before starting patients on this medication to exclude preexisting papilledema. If patients have papilledema, providers should treat its underlying cause before initiating treatment. Patients should stop taking the drug if papilledema occurs during treatment.
Common adverse events include back pain, arthralgia, dyspepsia, sleep disorder, dizziness, tonsillitis, peripheral edema, vomiting, adrenal insufficiency, hypertension, increased blood creatine phosphokinase, weight gain, and anemia. Patients with an acute critical illness, active malignancy, hypersensitivity to somapacitanbeco and its excipients, or active proliferative or severe nonproliferative diabetic retinopathy should not take this medication.
This drug may interact with replacement glucocorticoid treatment, cytochrome P450–metabolized drugs, oral estrogen, and insulin or other hypoglycemic agents. Patients taking somapacitan-beco at the same time as these treatments may require dose adjustments and should be monitored.