Select therapeutic use:

Bladder, kidney, and other urologic cancers:

Indications for BAVENCIO:

Locally advanced or metastatic urothelial carcinoma (UC) in patients who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. In combination with axitinib for the first-line treatment of advanced renal cell carcinoma (RCC).

Adult:

Premedicate with an antihistamine and acetaminophen prior to the first 4 infusions; then subsequent doses as clinically indicated. Give as IV infusion over 60mins. 800mg every 2 weeks until disease progression or unacceptable toxicity. RCC: give in combination with axitinib 5mg every 12hrs (may increase axitinib dose at intervals of 2 weeks or longer). Dose modifications: see full labeling.

Children:

<12yrs: not established.

Warnings/Precautions:

See full labeling. Monitor for any immune-mediated adverse reactions; permanently discontinue or withhold, and give corticosteroids (at 1–2mg/kg/day prednisone equivalents) based on severity of event. Permanently discontinue for Grade 3/4 pneumonitis or recurrent Grade 2 pneumonitis, Grade 4 diarrhea or colitis or recurrent Grade 3 diarrhea or colitis, AST/ALT >5×ULN or total bilirubin >3×ULN (AST/ALT ≥5×ULN or >3×ULN with concurrent total bilirubin ≥2×ULN or total bilirubin ≥3×ULN when in combination with axitinib), SCr >6×ULN, any life-threatening (Grade 4, except endocrinopathies) or recurrent severe (Grade 3) immune-mediated adverse reactions, requirement for ≥10mg/day prednisone (or equivalent) for >12 weeks, or persistent Grade 2/3 immune-mediated adverse reactions lasting ≥12 weeks. Grade 2 pneumonitis, Grade 2/3 diarrhea or colitis, Grade 3/4 adrenal insufficiency, Grade 3/4 thyroid disorders, Grade 3/4 hyperglycemia, AST/ALT >3–5×ULN or total bilirubin >1.5–3×ULN (AST/ALT ≥3–<5×ULN or total bilirubin ≥1.5–<3×ULN when in combination with axitinib), SCr >1.5–6×ULN; withhold dose, give corticosteroids, and resume when return to Grade 0 or 1. Interrupt or decrease infusion rate if Grade 1/2 infusion-related reactions occur; permanently discontinue if Grade 3/4. Monitor for abnormal liver tests, adrenal insufficiency, elevated serum creatinine, hyperglycemia, and thyroid function prior to and during treatment; give replacement therapy for hypothyroidism. In combination with axitinib: risk of severe and fatal cardiovascular events; discontinue both drugs if Grade 3/4 occurs; monitor LVEF at baseline and periodically. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for ≥1 month after final dose. Pregnancy: avoid. Nursing mothers: not recommended (during and for ≥1 month after final dose).

Pharmacologic Class:

Programmed death-ligand 1 (PD-L1) blocking antibody.

Interactions:

Increased hepatotoxicity (in combination with axitinib); monitor liver enzymes more frequently.

Adverse Reactions:

Fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reaction, rash, decreased appetite, peripheral edema, UTI, hypertension, mucositis, palmar-plantar erythrodysesthesia, dysphonia, hypothyroidism, hepatotoxicity, cough, dyspnea, abdominal pain, headache; other immune-mediated adverse reactions (may be fatal).

Generic Availability:

NO

How Supplied:

Single-dose vial (10mL)—1

Melanoma and other skin cancers:

Indications for BAVENCIO:

Metastatic Merkel cell carcinoma (MCC).

Adult:

Premedicate with an antihistamine and acetaminophen prior to the first 4 infusions; then subsequent doses as clinically indicated. Give as IV infusion over 60mins. 800mg every 2 weeks until disease progression or unacceptable toxicity. Dose modifications: see full labeling.

Children:

<12yrs: not established.

Warnings/Precautions:

See full labeling. Monitor for any immune-mediated adverse reactions; permanently discontinue or withhold, and give corticosteroids (at 1–2mg/kg/day prednisone equivalents) based on severity of event. Permanently discontinue for Grade 3/4 pneumonitis or recurrent Grade 2 pneumonitis, Grade 4 diarrhea or colitis or recurrent Grade 3 diarrhea or colitis, AST/ALT >5×ULN or total bilirubin >3×ULN (AST/ALT ≥5×ULN or >3×ULN with concurrent total bilirubin ≥2×ULN or total bilirubin ≥3×ULN when in combination with axitinib), SCr >6×ULN, any life-threatening (Grade 4, except endocrinopathies) or recurrent severe (Grade 3) immune-mediated adverse reactions, requirement for ≥10mg/day prednisone (or equivalent) for >12 weeks, or persistent Grade 2/3 immune-mediated adverse reactions lasting ≥12 weeks. Grade 2 pneumonitis, Grade 2/3 diarrhea or colitis, Grade 3/4 adrenal insufficiency, Grade 3/4 thyroid disorders, Grade 3/4 hyperglycemia, AST/ALT >3–5×ULN or total bilirubin >1.5–3×ULN (AST/ALT ≥3–<5×ULN or total bilirubin ≥1.5–<3×ULN when in combination with axitinib), SCr >1.5–6×ULN; withhold dose, give corticosteroids, and resume when return to Grade 0 or 1. Interrupt or decrease infusion rate if Grade 1/2 infusion-related reactions occur; permanently discontinue if Grade 3/4. Monitor for abnormal liver tests, adrenal insufficiency, elevated serum creatinine, hyperglycemia, and thyroid function prior to and during treatment; give replacement therapy for hypothyroidism. In combination with axitinib: risk of severe and fatal cardiovascular events; discontinue both drugs if Grade 3/4 occurs; monitor LVEF at baseline and periodically. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for ≥1 month after final dose. Pregnancy: avoid. Nursing mothers: not recommended (during and for ≥1 month after final dose).

Pharmacologic Class:

Programmed death-ligand 1 (PD-L1) blocking antibody.

Interactions:

Increased hepatotoxicity (in combination with axitinib); monitor liver enzymes more frequently.

Adverse Reactions:

Fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reaction, rash, decreased appetite, peripheral edema, UTI, hypertension, mucositis, palmar-plantar erythrodysesthesia, dysphonia, hypothyroidism, hepatotoxicity, cough, dyspnea, abdominal pain, headache; other immune-mediated adverse reactions (may be fatal).

Generic Availability:

NO

How Supplied:

Single-dose vial (10mL)—1