Indications for: JEMPERLI
In adults with mismatch repair deficient (dMMR) recurrent or advanced solid tumors, as determined by an FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options.
Give by IV infusion over 30mins. Dose 1–4: 500mg every 3 weeks; Dose 5 onwards (beginning 3 weeks after Dose 4): 1000mg every 6 weeks. Continue until disease progression or unacceptable toxicity. Dose modifications for adverse reactions: see full labeling.
Severe and fatal immune-mediated adverse reactions can develop. Monitor closely for immune-related pneumonitis, hepatitis (with or without liver tumor involvement), colitis, endocrinopathies (thyroid disorders, adrenal insufficiency, diabetes, hypophysitis/hypopituitarism), nephritis/renal dysfunction, dermatologic reactions, myocarditis, neurological toxicities, others. Withhold or permanently discontinue based on severity and type of adverse reaction; see full labeling for management guidelines. Obtain liver enzymes, creatinine and thyroid function at baseline and periodically during therapy. Monitor for infection. Evaluate for Vogt-Koyanagi-Harada-like syndrome if uveitis in combination with other immune-mediated reactions occur. Interrupt, slow the infusion rate, or permanently discontinue based on severity of infusion-related reactions. Monitor closely for allogeneic HSCT-related complications (eg, graft-versus-host-disease, hepatic veno-occlusive disease, steroid-requiring febrile syndrome) and manage promptly. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for 4 months after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 4 months after the last dose).
Programmed death receptor-1 (PD-1) blocking antibody.
Fatigue/asthenia, nausea, diarrhea, anemia, constipation; sepsis, acute kidney injury, UTI, abdominal pain, pyrexia; other immune-mediated adverse reactions (eg, ocular, gastrointestinal, musculoskeletal/connective tissue, hematologic/immune), infusion-related reactions.
Half-life: 23.5 days.
Generic Drug Availability:
Single-dose vial (10mL)—1