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New & Approved

Adagrasib (Krazati—Mirati Therapeutics)

Drug class: Adagrasib is an inhibitor of the RAS GTPase family.

Indication: Krazati is indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer, as determined by an FDA-approved test, who have received at least one prior systemic therapy. This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of a clinical benefit in a confirmatory trial.

Recommended dosage and administration: The recommended dosage is 600 mg orally twice daily. Krazati tablets should be swallowed whole with or without food.

Common adverse effects: The most common adverse reactions were nausea, diarrhea, vomiting, fatigue, musculoskeletal pain, hepatotoxicity, renal impairment, edema, dyspnea, decreased appetite, decreased lymphocytes, decreased hemoglobin, increased ALT, increased AST, hypokalemia, hyponatremia, increased lipase, decreased leukocytes, decreased neutrophils, and increased alkaline phosphatase.

Warnings and precautions: Monitor patients for diarrhea, nausea, and vomiting and provide supportive care as needed. Withhold, reduce the dose, or permanently discontinue based on severity. Avoid concomitant use of Krazati with other products with a known potential to prolong QTc intervals. Monitor ECG and electrolytes in patients at risk, and in patients taking medications known to prolong the QT interval. Withhold, reduce the dose, or permanently discontinue based on severity. Monitor liver laboratory tests prior to the start of Krazati and monthly for 3 months after and as clinically indicated. Reduce the dose, withhold, or permanently discontinue based on severity. Monitor for new or worsening respiratory symptoms. Withhold Krazati for suspected interstitial lung disease (ILD)/pneumonitis and permanently discontinue if no other potential causes of ILD/pneumonitis are identified. Avoid concomitant use with strong CYP3A4 inducers. Avoid concomitant use with strong CYP3A4 substrates until Krazati concentrations have reached steady state. Avoid concomitant use with sensitive CYP3A4 substrates. Avoid concomitant use with sensitive CYP2C9 or CYP2D6 substrates or P-gp substrates where minimal concentration changes may lead to serious adverse reactions. Advise patients not to breastfeed while taking Krazati.

Olutasidenib (Rezlidhia—Rigel Pharmaceuticals)

Drug class: Olutasidenib is an isocitrate dehydrogenase-1 (IDH1) inhibitor.

Indication: Rezlidhia is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia with a susceptible IDH1 mutation as detected by an FDA-approved test.

Recommended dosage and administration: The recommended dosage is 150 mg orally twice daily, until disease progression, or unacceptable toxicity. Rezlidhia should be taken on an empty stomach at least 1 hour before or 2 hours after a meal.

Common adverse effects: The most common adverse reactions in patients taking Rezlidhia include increased AST, increased ALT, decreased potassium, decreased sodium, increased alkaline phosphatase, nausea, increased creatinine, fatigue, arthralgia, constipation, increased lymphocytes, increased bilirubin, leukocytosis, increased uric acid, dyspnea, pyrexia, rash, increased lipase, mucositis, diarrhea, and transaminitis.

Boxed warning: Differentiation syndrome, which can be fatal, can occur with Rezlidhia treatment. If differentiation syndrome is suspected, withhold Rezlidhia, and initiate corticosteroids and hemodynamic monitoring until symptom resolution.

Other warnings and precautions: Monitor liver function tests during treatment with Rezlidhia. If hepatotoxicity occurs, interrupt and reduce or discontinue Rezlidhia. Patients should be advised not to breastfeed while taking Rezlidhia. Avoid concomitant use with strong or moderate CYP3A inducers. Avoid concomitant use with sensitive CYP3A substrates and monitor if concomitant use is unavoidable.

Xenon xe 129 hyperpolarized (Xenoview—Polarean Inc.)

Drug class: Xenoview, prepared from the Xenon Xe 129 Gas Blend, is a hyperpolarized contrast agent.

Indication: Xenoview is indicated for use with magnetic resonance imaging for evaluation of lung ventilation in adults and pediatric patients aged 12 years and older.

Recommended dosage and administration: The recommended target dose of Xenoview for adult and pediatric patients aged 12 years and older is 75 mL to 100 mL dose equivalent (DE) of hyperpolarized xenon Xe 129 by oral inhalation of the entire contents of one Xenoview Dose Delivery Bag. Each bag contains at least 75 mL DE of hyperpolarized xenon Xe 129 with a recommended targe DE range of 75 mL to 100 mL measured within 5 minutes of administration, in a volume of 250 mL to 750 mL total xenon with additional nitrogen, with NF added to reach a total volume of 1,000 mL. Administer dose within 5 minutes of DE measurement and initiate imaging immediately after inhalation.

Common adverse effects: The most common adverse reactions were oropharyngeal pain, headache, and dizziness.

Warnings and precautions: Xenoview has not been evaluated for use with lung perfusion imaging. Supplemental oxygen administered simultaneously with Xenoview inhalation can cause degradation of image quality. For patients on supplemental oxygen, withhold oxygen inhalation for 2 breaths prior to Xenoview inhalation, and resume oxygen inhalation immediately following the imaging breath hold. Inhalation of anoxic gas such as Xenoview may cause transient hypoxemia in susceptible patients. Monitor all patients for oxygen saturation and symptoms of hypoxemia and treat as clinically indicated.

Ublituximab-xiiy (Briumvi—TG Therapeutics)

Drug class: Briumvi is a CD20-directed cytolytic antibody.

Indication: Briumvi is indicated for the treatment of relapsing forms of multiple sclerosis in adults to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

Recommended dosage and administration: Prior to initiating therapy, Hepatitis B virus and quantitative serum immunoglobulin screening are required. Premedicate with methylprednisolone and an antihistamine prior to each infusion. Administer Briumvi by I.V. infusion. The first infusion should be 150 mg and the second infusion, administered 2 weeks after the first, should be 450 mg. Subsequent infusions should be 450 mg 24 weeks after the first infusion and every 24 weeks thereafter. Briumvi must be diluted in 0.9% sodium chloride prior to administration. Patients should be closely monitored during and for at least 1 hour after the completion of the first 2 infusions.

Common adverse effects: The most common adverse reactions were infusion reactions and upper respiratory tract infections.

Warnings and precautions: Briumvi is contraindicated in active hepatitis B virus infection and history of life-threatening infusion reaction to Briumvi. Monitor patients for infusion reactions and permanently discontinue Briumvi if a life-threatening or disabling infusion reaction occurs. Serious, including life-threatening and fatal infections, have occurred. Delay Briumvi administration in patients with an active infection until after the infection has resolved. Vaccination with live-attenuated or live vaccines is not recommended during treatment and after discontinuation, until B-cell repletion. Monitor the level of immunoglobulins at the beginning, during, and after discontinuation of treatment with Briumvi, until B-cell repletion, and especially when recurrent serious infections are suspected. Briumvi may cause fetal harm and patients of reproductive potential should be informed of the potential risk to a fetus and to use contraception during treatment and for at least 6 months after stopping Briumvi.

Enacapavir (Sunlenca—Gilead Sciences)

Drug class: Lenacapavir is a human immunodeficiency virus type 1 (HIV-1) capsid inhibitor.

Indication: Sunlenca is indicated, in combination with other antiretrovirals, for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen due to resistance, intolerance, or safety considerations.

Recommended dosage and administration: Initiation of Sunlenca should follow 1 of 2 options and then maintenance dosing once every 6 months. Tablets should be taken without regard to food. The first initiation dosing option is 927 mg S.C. injection and 600 mg orally on day 1 followed by 600 mg orally on day 2. The second initiation dosing option is 600 mg orally on days 1 and 2, 300 mg orally on day 8, and 927 mg by S.C. injection on day 15. The maintenance dose is 927 mg by S.C. injection every 6 months from the date of the last injection +/- 2 weeks. If more than 28 weeks has passed since the last injection and it is clinically appropriate to continue Sunlenca, restart initiation from day 1, using either option 1 or option 2.

Common adverse effects: The most common adverse reactions are nausea and injection site reactions.

Warnings and precautions: Concomitant administration of Sunlenca with strong CYP3A inhibitors is contraindicated. If immune reconstitution syndrome occurs, further evaluation and treatment may be necessary. Residual concentrations of lenacapavir may remain in systemic circulation for up to 12 months or longer.

Counsel patients regarding the dosing schedule, as nonadherence could lead to loss of virologic response and development of resistance. Sunlenca may increase exposure and risk of adverse reactions to drugs primarily metabolized by CYP3A that are initiated within 9 months after the last Sunlenca dose. If discontinued, initiate an alternative, fully suppressive antiretroviral regimen where possible no later than 29 weeks after the final injection of Sunlenca. If virologic failure occurs, switch to an alternative regimen if possible. Injection site reactions may occur, and nodules and indurations may be persistent. Individuals infected with HIV should be instructed not to breastfeed due to the potential for HIV transmission. ■



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