avelumab

REMS

Metastatic Merkel cell carcinoma (MCC).
Maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma that has not progressed with first-line platinum-containing chemotherapy.
Locally advanced or metastatic urothelial carcinoma in patients who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 mo of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
Advanced renal cell carcinoma (RCC) as first-line therapy (in combination with axitinib).

Contraind./Precautions ⬆ ⬇

Contraindicated in:

OB: Pregnancy (may cause fetal harm)
Lactation: Lactation.

Use Cautiously in:

Diabetes, hypertension, and/or dyslipidemia
Rep: Women of reproductive potential
Pedi: Children <12 yr (safety and effectiveness not established).

Adv. Reactions/Side Effects ⬆ ⬇

CV: MYOCARDITIS, HF, MI, hypertension, peripheral edema, pericarditis, vasculitis.

Derm: DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS, STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS, pruritus, rash.

EENT: iritis, uveitis.

Endo: ADRENAL INSUFFICIENCY, hypothyroidism, hyperthyroidism, hypoparathyroidism, hypophysitis, type 1 diabetes.

F and E: hyponatremia, hyperkalemia.

GI: COLITIS, HEPATITIS, abdominal pain, constipation, ↓appetite, diarrhea, ↑lipase, ↑liver enzymes, nausea, vomiting, gastritis, ↑ amylase, pancreatitis.

GU: urinary tract infection, nephritis.

Hemat: anemia, lymphopenia, thrombocytopenia, hemolytic anemia, neutropenia.

Metab: ↓weight.

MS: RHABDOMYOLYSIS, pain, myositis.

Neuro: autoimmune neuropathy, Guillain-Barré syndrome, myasthenic syndrome, myelitis , ENCEPHALITIS, MENINGITIS, dizziness, headache.

Resp: PNEUMONITIS, cough, dyspnea, fever.

Misc: infusion-related reactions, fatigue.

Interactions ⬆ ⬇

Drug-Drug:

None reported.

Availability ⬆ ⬇

Solution for injection: 20 mg/mL;

Route/Dosage ⬆ ⬇

MCC

IV (Adults and Children 12 yr): 800 mg every 2 wk until disease progression or unacceptable toxicity.

Urothelial Carcinoma and RCC

IV (Adults): 800 mg every 2 wk until disease progression or unacceptable toxicity.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Binds to programmed death ligand 1 (PD-L1) to prevent its interaction with the programmed cell death-1 (PD-1) and B7.1 (or CD80) receptors, which activates the antitumor immune response.

Therapeutic Effects:

Decreased spread of MCC.
Decreased spread of and improved survival in urothelial carcinoma.
Improved progression-free survival in RCC.

Classifications ⬆ ⬇

Therapeutic Classification: antineoplastics

Pharmacologic Classification: monoclonal antibodies

Pharmacokinetics ⬆ ⬇

Absorption: IV administration results in complete bioavailability.

Distribution: Minimally distributed to tissues.

Metabolism/Excretion: Primarily eliminated via proteolytic degradation.

Half-life: 6.1 days.

Time/Action Profile ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
IV	unknown	unknown	unknown

Patient/Family Teaching ⬆ ⬇

Explain purpose of avelumab to patient and family and inform of potential adverse reactions.
Instruct patient to notify health care professional immediately is signs and symptoms of infusion reactions occur.
Advise patient to notify health are professional immediately if signs and symptoms of pneumonitis; hepatitis (jaundice, severe nausea or vomiting, pain on right side of abdomen, lethargy, or easy bruising or bleeding); colitis; adrenal insufficiency (hypotension, weight loss, weakness, nausea, vomiting, anorexia, lethargy, confusion, restlessness); hypothyroidism (intolerance to cold, constipation, dry skin, headache, listlessness, tiredness, or weakness); hyperthyroidism (headache, nervousness, diarrhea, excessive sweating, heat intolerance, chest pain, increased pulse rate, palpitations, weight loss >2 lb/wk); diabetes mellitus (confusion, drowsiness; flushed, dry skin; fruit-like breath odor; rapid, deep breathing, polyuria; loss of appetite; unusual thirst); nephritis (decreased urine output, blood in urine, swelling in ankles, loss of appetite), skin reactions (rash, itching, rash with tiny spots or bumps, reddening of skin, blisters, peeling); or cardiovascular events (new or worsening chest discomfort, pain or pressure; swelling in feet or ankles; shortness of breath; nausea or vomiting; weight gain; pain or discomfort in arms, back, neck, or jaw, cold sweat; lightheadedness or dizziness) occur.
Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking other Rx, OTC, herbal products.
Rep: Advise females of reproductive potential to use effective contraception and avoid breast feeding during and for at least 1 month after last dose of avelumab.

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Indications ⬇