avelumab (Rx)

Brand and Other Names:Bavencio
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

solution for injection

  • 20mg/mL (200mg/10mL vial)

Merkel Cell Carcinoma

Indicated for metastatic Merkel cell carcinoma (MCC) in adults and pediatric patients aged ≥12 yr

10 mg/kg IV q2wk

Continue until disease progression or unacceptable toxicity

Also see Administration

Urothelial Carcinoma

Indicated for locally advanced or metastatic urothelial carcinoma (UC) in patients who have disease progression during or following platinum-containing chemotherapy or disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy

10 mg/kg IV q2wk

Continue until disease progression or unacceptable toxicity

Also see Administration

Dosage Modifications

Withhold for any of the following (may resume when recover to grade 0-1)

  • Grade 2 pneumonitis
  • Grade 2 or 3 diarrhea or colitis
  • Grade 3 or 4 endocrinopathies
  • Serum creatinine >1.5 and up to 6 x ULN AST or ALT >3 and up to 5 x ULN or total bilirubin >1.4 and up to 3 x ULN
  • Any other severe or grade 3 treatment-related adverse reaction

Permanently discontinue for any of the following

  • Any life-threatening adverse reaction (excluding endocrinopathies controlled with hormone replacement therapy)
  • Grade 3 or 4 pneumonitis or recurrent grade 2 pneumonitis
  • Grade 4 diarrhea or colitis or recurrent grade 3 diarrhea or colitis
  • Serum creatinine >6 x ULN AST or ALT >5 x ULN or total bilirubin >3 x ULN
  • Grade 3 or 4 infusion-related reactions
  • Inability to reduce corticosteroid dose to ≤10 mg/day of prednisone or equivalent within 12 weeks
  • Persistent grade 2 or 3 adverse reactions that do not recover to grade 0-1 within 12 weeks after last dose
  • Any severe or grade 3 treatment-related adverse reaction that recurs

Dosing Considerations

MCC and UC: Approved under accelerated approval based on tumor response and duration of response; continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials

Orphan Designations

Treatment of gastric cancer (GC) including cancer of the gastroesophageal junction (GEJ)

Sponsor

  • EMD Serono Research & Development Institute, Inc. 45A Middlesex Turnpike Billerica, Massachusetts 01821 USA

Dosage Forms & Strengths

solution for injection

  • 20mg/mL (200mg/10mL vial)

Merkel Cell Carcinoma

Indicated for metastatic Merkel cell carcinoma (MCC) in adults and pediatric patients aged ≥12 yr

<12 years: Safety and efficacy not established

≥12 years: 10 mg/kg IV q2wk

Continue until disease progression or unacceptable toxicity

Also see Administration

Dosage Modifications

Withhold for any of the following (may resume when recover to grade 0-1)

  • Grade 2 pneumonitis
  • Grade 2 or 3 diarrhea or colitis
  • Grade 3 or 4 endocrinopathies
  • Serum creatinine >1.5 and up to 6 x ULN AST or ALT >3 and up to 5 x ULN or total bilirubin >1.4 and up to 3 x ULN
  • Any other severe or grade 3 treatment-related adverse reaction

Permanently discontinue for any of the following

  • Any life-threatening adverse reaction (excluding endocrinopathies controlled with hormone replacement therapy)
  • Grade 3 or 4 pneumonitis or recurrent grade 2 pneumonitis
  • Grade 4 diarrhea or colitis or recurrent grade 3 diarrhea or colitis
  • Serum creatinine >6 x ULN AST or ALT >5 x ULN or total bilirubin >3 x ULN
  • Grade 3 or 4 infusion-related reactions
  • Inability to reduce corticosteroid dose to ≤10 mg/day of prednisone or equivalent within 12 weeks
  • Persistent grade 2 or 3 adverse reactions that do not recover to grade 0-1 within 12 weeks after last dose
  • Any severe or grade 3 treatment-related adverse reaction that recurs

Dosing Considerations

MCC: Approved under accelerated approval based on tumor response and duration of response; continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials

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Adverse Effects

Adverse effects include all grades unless otherwise stated

>10%

Fatigue (50%)

Musculoskeletal pain (32%)

Diarrhea (23%)

Nausea (22%)

Infusion-related reaction (22%)

Rash (22%)

Peripheral edema (20%)

Decreased appetite (20%)

Cough (18%)

Constipation (17%)

Abdominal pain (16%)

Arthralgia (16%)

Decreased weight (15%)

Dizziness (14%)

Vomiting (13%)

Hypertension (13%)

Dyspnea (11%)

1-10%

Pruritus (10%)

Headache (10%)

Thyroid disorders (6%)

Hypertension, grade 3 or 4 (6%)

Decreased appetite, grade 3 or 4 (2%)

Abdominal pain, grade 3 or 4 (2%)

Musculoskeletal pain, grade 3 or 4 (2%)

Fatigue, grade 3 or 4 (2%)

Colitis (1.5%)

Pneumonitis (1.2%)

Constipation, grade 3 or 4 (1%)

Arthralgia, grade 3 or 4 (1%)

<1%

Hepatitis

Adrenal insufficiency

Type 1 diabetes mellitus

Nephritis

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Warnings

Contraindications

None

Cautions

Clinical trials reported immune-mediated pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, and other immune-mediated adverse reactions (eg, uveitis, arthritis, myositis, pancreatitis, hemolytic anemia, partial seizures arising in a patient with inflammatory foci in brain parenchyma, myasthenic syndrome, optic neuritis, rhabdomyolysis) (see Dosage Modifications for guidance on withholding or discontinuing the drug)

Immune-mediated hepatitis, including fatal cases, reported; monitor LFTs before initiating and periodically during treatment; administer corticosteroids (initial dose of 1-2 mg/kg/day prednisone or equivalent, followed by taper) for ≥grade 2 hepatitis (see Dosage Modifications)

Monitor for symptoms of immune-mediated colitis; administer corticosteroids (initial dose of 1-2 mg/kg/day prednisone or equivalent, followed by taper) for ≥grade 2 colitis until resolution (see Dosage Modifications)

Immune-mediated adrenal insufficiency should be treated with corticosteroids as appropriate for the adrenal insufficiency (See Dosage Modifications)

Immune-mediated endocrinopathies also include hypothyroidism or hyperthyroidism; monitor thyroid function before initiating drug and during treatment; treat hypothyroidism with hormone-replacement therapy; initiate medical management for control of hyperthyroidism

Immune-mediated nephritis and renal dysfunction reported; monitor for elevated serum creatinine before treatment and periodically during treatment; administer corticosteroids (initial dose of 1-2 mg/kg/day prednisone or equivalent, followed by taper) for ≥grade 2 nephritis until resolution (see Dosage Modifications)

Type 1 diabetes mellitus, including diabetic ketoacidosis, reported; monitor for hyperglycemia or other signs and symptoms of diabetes; may resume avelumab when metabolic control is achieved with insulin or antihyperglycemics (see Dosage Modifications)

Infusion-related reactions, including severe and life-threatening reactions, reported; monitor patients for signs and symptoms of infusion-related reactions, including rigors, chills, wheezing, pruritus, flushing, rash, hypotension, hypoxemia, and fever; interrupt or slow infusion rate for grade 1 or 2 reaction; permanently discontinue therapy for severe (grade 3) or life-threatening (grade 4) infusion-related reactions

Embryo-fetal toxicity is possible based on its mechanism of action; advise females of reproductive potential to use effective contraception during treatment and for at least 1 month after the last dose (see Pregnancy)

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Pregnancy

Pregnancy

Based on its mechanism of action, can cause fetal harm when administered to a pregnant woman

Animal studies have demonstrated that inhibition of the PD-1/PD-L1 pathway can lead to increased risk of immune-mediated rejection of the developing fetus, resulting in fetal death

If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, advise the patient of the potential risk to a fetus

Contraception

  • Advise females of reproductive potential to use effective contraception during treatment and for at least 1 month after the last dose

Lactation

Unknown if distributed in human breast milk

Advise a lactating woman not to breastfeed during treatment and for at least 1 month after the last dose owing to the potential for serious adverse reactions in breastfed infants

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

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Pharmacology

Mechanism of Action

Anti-PD-L1 IgG1 monoclonal antibody

PD-L1 may be expressed on tumor cells and tumor-infiltrating immune cells and can contribute to the inhibition of the antitumor immune response in the tumor microenvironment

Binding of PD-L1 to the PD-1 and B7.1 receptors found on T cells and antigen-presenting cells suppresses cytotoxic T-cell activity, T-cell proliferation, and cytokine production

Avelumab binds PD-L1 and blocks the interaction between PD-L1 and its receptors PD-1 and B7.1; this interaction releases the inhibitory effects of PD-L1 on the immune response, resulting in the restoration of immune responses, including antitumor immune responses

Distribution

Vd: 4.72 L

Elimination

Half-life: 6.1 days

Primary elimination mechanism is proteolytic degradation

Total systemic clearance: 0.59 L/day

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Administration

IV Compatibilities

0.45% NaCl

0.9% NaCl

IV Preparation

Visually inspect vial for particulate matter and discoloration

Should appear as a clear, colorless to slightly yellow solution

Discard vial if the solution is cloudy, discolored, or contains particulate matter

Withdraw the required dosage volume from the vial(s) and inject it into a 250-mL infusion bag containing either 0.9% or 0.45% NaCl

Gently invert the bag to mix the diluted solution and avoid foaming or excessive shearing

Inspect the admixture solution to ensure it is clear, colorless, and free of visible particles

Discard any partially used or empty vials

IV Administration

Infuse IV over 60 minutes through an IV line containing a sterile, nonpyrogenic, low protein-binding inline filter (pore size of 0.2 micron)

Do not coadminister other drugs through the same IV line

Premedication

  • Premedicate with an antihistamine and acetaminophen before the first 4 infusions
  • Premedication for subsequent doses should be based on clinical judgment and presence/severity of prior infusion reactions

Storage

Unopened vials

  • Store refrigerated at 36-46°F (2-8°C) in original package to protect from light
  • Do not freeze or shake vials
  • The vial stopper is not made with natural rubber latex

Diluted solution

  • Room temperature (up to 77°F [25°C]): Store for no more than 4 hr from the time of dilution, OR
  • Refrigerated (36-46°F [2-8°C]): Store for no more than 24 hr from the time of dilution; if refrigerated, allow the diluted solution to come to room temperature before administering
  • Do not freeze or shake diluted solution
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Images

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Formulary

FormularyPatient Discounts

Adding plans allows you to compare formulary status to other drugs in the same class.

To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

Adding plans allows you to:

  • View the formulary and any restrictions for each plan.
  • Manage and view all your plans together – even plans in different states.
  • Compare formulary status to other drugs in the same class.
  • Access your plan list on any device – mobile or desktop.

The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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