New drugs
AVACINCAPTAD PEGOL INTRAVITREAL SOLUTION
(Izervay—Iveric Bio)
Drug class: Izervay is a complement inhibitor.
Indication: Izervay is indicated for the treatment of geographic atrophy secondary to age-related macular degeneration.
Recommended dosage and administration: The recommended dose for Izervay is 2 mg (0.1 mL of 10 mg/mL solution) administered by intravitreal injection to each affected eye once monthly for up to 12 months.
Common adverse effects: The most common adverse reactions were conjunctival hemorrhage, increased intraocular pressure, blurred vision, and neovascular age-related macular degeneration.
Warnings and precautions: Izervay is contraindicated in ocular or periocular infections and active intraocular inflammation. Endophthalmitis and retinal detachments may occur with use.
PALOVAROTENE
(Sohonos—Ipsen Inc.)
Drug class: Sohonos is a retinoid.
Indication: Sohonos is indicated for reduction in the volume of new heterotopic ossification in adults and children aged 8 years and older for females and 10 years and older for males with fibrodysplasia ossificans progressiva.
Recommended dosage and administration: Obtain a negative pregnancy test in females of reproductive potential before initiation of Sohonos. The recommended dosage includes a chronic daily dose, which can be increased for flare-up symptoms. For adults and pediatric patients 14 years and older, the recommended dosage is 5 mg once daily, with an increase in dose at the time of flare-up to 20 mg once daily for 4 weeks, followed by 10 mg once daily for 8 weeks for a total of 12 weeks. For pediatric patients under 14 years, the recommended dosage is weight-adjusted for daily and flare-up dosing, with the daily dosage ranging from 2.5 mg to 5 mg. Take Sohonos with food, preferably at the same time each day. Reduce the dose in the event of adverse reactions as appropriate.
Common adverse effects: The most common adverse reactions are dry skin, dry lips, arthralgia, pruritis, pain in extremities, rash, alopecia, erythema, headache, back pain, skin exfoliation, nausea, musculoskeletal pain, myalgia, dry eye, hypersensitivity, peripheral edema, and fatigue.
Boxed warning: Sohonos is contraindicated in pregnancy because of the risk of teratogenicity. To minimize fetal exposure, Sohonos is to be administered only if conditions for pregnancy prevention are met. Sohonos causes premature epiphyseal closure in growing pediatric patients with fibrodysplasia ossificans progressiva, so close monitoring is recommended.
Warnings and precautions: Sohonos is contraindicated in pregnancy and hypersensitivity to retinoids or any component of Sohonos. Premature epiphyseal closure occurred with Sohonos. Assess baseline skeletal maturity before Sohonos therapy and monitor linear growth in growing pediatric patients. Dry skin, dry lips, pruritis, rash, alopecia, erythema, skin exfoliation, and dry eye occurred with Sohonos. Prevent or treat with skin emollients, sunscreen, and artificial tears. Dosage reduction may be required in some patients. Decreased vertebral bone mineral content and bone density may occur. Assess for spinal fracture periodically using radiologic methods. Depression, anxiety, mood alterations, and suicidal thoughts and behaviors have occurred in patients taking Sohonos. Contact a health care provider if new or worsening symptoms develop in patients treated with Sohonos. Night blindness may occur and make driving at night hazardous. Avoid concomitant use of strong or moderate CYP3A4 inhibitors as well as grapefruit, pomelo, or juices containing these fruits, as this may increase Sohonos exposure. Avoid concomitant use of strong or moderate CYP3A4 inducers, as this may decrease Sohonos exposure. Taking Sohonos concomitantly with vitamin A may cause additive effects. Avoid concomitant use of tetracyclines with Sohonos. No clinically significant drug interaction is expected with concomitant use of systemic corticosteroids.
ZURANOLONE
(Zurzuvae—Sage Therapeutics)
Drug class: Zurzuvae is a neuroactive steroid gamma-aminobutyric acid A receptor positive modulator.
Indication: Zurzuvae is indicated for the treatment of postpartum depression in adults.
Recommended dosage and administration: The recommended dosage is 50 mg orally once daily in the evening for 14 days. Dosage may be reduced to 40 mg once daily if central nervous system (CNS) depressant effects occur. Zurzuvae should be administered with a fat-containing food. Zurzuvae can be used alone or as an adjunct to oral antidepressant therapy. In severe hepatic impairment, the recommended dosage is 30 mg orally once daily in the evening for 14 days. In moderate or severe renal impairment, the recommended dosage is 30 mg orally once daily in the evening for 14 days.
Common adverse effects: The most common adverse reactions were somnolence, dizziness, diarrhea, fatigue, nasopharyngitis, and UTI.
Boxed warning: Zurzuvae causes driving impairment due to CNS depressant effects. Advise patients not to drive or engage in other potentially hazardous activities until at least 12 hours after administration. Patients may not be able to assess their own driving competence or the degree of impairment caused by Zurzuvae.
Warnings and precautions: Zurzuvae can cause CNS depressant effects such as somnolence and confusion. If patients develop CNS depression, consider dosage reduction or discontinuation of Zurzuvae. Consider changing the therapeutic regimen, including discontinuing Zurzuvae, in patients whose postpartum depression worsens or who experience emergent suicidal thoughts and behaviors. Zurzuvae may cause fetal harm. Advise patients of the potential risk to an infant exposed to Zurzuvae in utero. Advise patients of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment and for 1 week after the final dose. Concomitant use with other CNS depressants may increase impairment of psychomotor performance or CNS depressant effects. If use with another CNS depressant is unavoidable, consider dosage reduction. Concomitant use with strong CYP3A4 inhibitors may increase the risk of Zurzuvae-associated adverse reactions. Reduce the Zurzuvae dosage to 30 mg orally once daily in the evening for 14 days when used concomitantly with a strong CYP3A4 inhibitor. Avoid concomitant use with CYP3A4 inducers, as concomitant use may decrease the efficacy of Zurzuvae.
New dosage forms
MELPHALAN
(Melphalan—Apotex)
Drug class: Melphalan is an alkylating drug.
Indication: Melphalan injection is indicated for palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate.
Recommended dosage and administration: The recommended dosage is 16 mg/m2 administered intravenously over 15 to 20 minutes at 2-week intervals for four doses, then, after adequate recovery from toxicity, at 4-week intervals.
Common adverse effects: The most common adverse reactions are decreased neutrophil count, decreased white blood cell count, decreased lymphocyte count, decreased platelet count, diarrhea, nausea, fatigue, hypokalemia, anemia, and vomiting.
Boxed warning: Severe bone suppression with resulting infection of bleeding may occur. Controlled trials comparing I.V. melphalan to oral melphalan have shown more myelosuppression with the I.V. formulation. Monitor hematologic parameters. Hypersensitivity reactions, including anaphylaxis, have occurred in approximately 2% of patients who received the I.V. formulation of melphalan. Discontinue treatment with melphalan injection for serious hypersensitivity reactions. Melphalan produces chromosomal aberrations in vitro and in vivo. Melphalan injection should be considered potentially leukemogenic in humans.
Warnings and precautions: Melphalan injection is contraindicated in those with a history of severe hypersensitivity to melphalan. Nausea, vomiting, diarrhea, or oral mucositis may occur. Provide supportive care using antiemetic and antidiarrheal medications as needed. Melphalan can cause fetal harm. Advise patients of reproductive potential and those with partners of reproductive potential of the potential risk to a fetus and to use effective contraception. Melphalan may cause ovarian function suppression or testicular suppression. Advise patients not to breastfeed during treatment. Consider a dosage reduction in renal insufficiency.
New combinations
NIRAPARIB AND ABIRATERONE ACETATE
(Akeega—Janssen Biotech)
Drug class: Akeega is a combination of niraparib, a poly (ADP-ribose) polymerase inhibitor, and abiraterone acetate, a CYP17 inhibitor.
Indication: Akeega is indicated with prednisone for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer. Select patients for therapy based on an FDA-approved test for Akeega.
Recommended dosage and administration: The recommended dosage for Akeega is 200 mg niraparib/1,000 mg abiraterone acetate orally once daily in combination with 10 mg prednisone daily until disease progression or unacceptable toxicity. Patients receiving Akeega should also receive a gonadotropin-releasing hormone analog concurrently or should have had bilateral orchiectomy. Take Akeega on an empty stomach. Do not eat food 2 hours before and 1 hour after taking Akeega.
Common adverse effects: The most common adverse reactions are decreased hemoglobin, decreased lymphocytes, decreased white blood cells, musculoskeletal pain, fatigue, decreased platelets, increased alkaline phosphatase, constipation, hypertension, nausea, decreased neutrophils, increased creatinine, increased potassium, decreased potassium, increased AST and ALT, edema, dyspnea, decreased appetite, vomiting, dizziness, COVID-19, headache, abdominal pain, hemorrhage, UTI, cough, insomnia, increased bilirubin, decreased weight, arrhythmia, fall, and pyrexia.
Warnings and precautions: Myelodysplastic syndrome and acute myeloid leukemia, including cases with fatal outcome, have been observed in patients treated with niraparib, a component of Akeega. Monitor patients for hematologic toxicity. Test complete blood counts weekly for the first month, every 2 weeks for the next 2 months, monthly for the remainder of the first year, then every other month, and as clinically indicated. Monitor patients for hypertension, hypokalemia, and fluid retention at least weekly for the first 2 months, then once a month. Closely monitor patients whose underlying medical conditions might be compromised by increases in BP, hypokalemia, or fluid retention. Monitor liver function and modify, interrupt, or discontinue treatment as recommended. Monitor for signs and symptoms of adrenocortical insufficiencies. Increased dosage of corticosteroids may be indicated, before, during, and after stressful situations. Monitor blood glucose in patients with diabetes and assess if antidiabetic agent dose modifications are required. Use of Akeega plus prednisone in combination with 223Ra dichloride is not recommended. Posterior reversible encephalopathy syndrome has been observed in patients treated with niraparib. Discontinue Akeega if this occurs. Akeega can cause fetal harm. Advise patients to use effective contraception. Avoid coadministration with strong CYP3A4 inducers. Avoid coadministration with CYP2D6 substrates for which minimal changes in concentration may lead to serious toxicities. Avoid use of Akeega in moderate or severe hepatic impairment. ■