durvalumab (Rx)

Brand and Other Names:Imfinzi
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

solution for injection

  • 120mg/2.4mL (50mg/mL) single-dose vial
  • 500mg/10mL (50mg/mL) single-dose vial

Urothelial Carcinoma

Indicated for locally advanced or metastatic urothelial carcinoma 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 infused over 1 hr

Continue until disease progression or unacceptable toxicity

Non-small Cell Lung Cancer

Indicated for unresectable, Stage III non-small cell lung cancer (NSCLC) in patients whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy

10 mg/kg IV q2wk infused over 1 hr

Continue until disease progression or unacceptable toxicity, or a maximum of 12 months

Dosage Modifications

No dose reductions are recommended; withhold and/or discontinue to manage adverse effects described below

Pneumonitis

  • Grade 2: Withhold dose; administer prednisone (or equivalent) 1-2 mg/kg/day PO followed by a taper
  • Grade 3 or 4: Permanently discontinue; administer prednisone (or equivalent) 1-4 mg/kg/day PO followed by a taper

Hepatitis

  • For each of the following parameters, administer prednisone (or equivalent) 1-2 mg/kg/day PO followed by a taper
  • Withhold dose
    • Grade 2 ALT or AST (>3-5 x ULN) or total bilirubin (TB) >1.5-3 x ULN
    • Grade 3 ALT or AST ≤8 x ULN or TB ≤5 x ULN
  • Permanently discontinue
    • Grade 3 ALT or AST >8 x ULN or TB >5 x ULN
    • Concurrent ALT or AST >3 x ULN and TB >2 x ULN with no other cause

Colitis or diarrhea

  • For each of the following parameters, administer prednisone (or equivalent) 1-2 mg/kg/day PO followed by a taper
  • Grade 2: Withhold dose
  • Grade 3 or 4: Permanently discontinue

Thyroid disorders

  • Hypothyroidism, grades 2-4: Initiate thyroid hormone replacement as clinically indicated
  • Hyperthyroidism, grades 2-4: Withhold dose until clinically stable and initiate symptomatic management

Adrenal insufficiency, hypophysitis/hypopituitarism

  • Grades 2-4: Withhold dose until clinically stable
  • Administer prednisone (or equivalent) 1-2 mg/kg/day PO followed by a taper
  • Administer hormone replacement as clinically indicated

Type 1 diabetes mellitus

  • Grades 2-4: Withhold dose until clinically stable
  • Initiate treatment with insulin as clinically indicated

Nephritis

  • For each of the following parameters, administer prednisone (or equivalent) 1-2 mg/kg/day PO followed by a taper
  • Grade 2 (creatinine >1.5-3 x ULN): Withhold dose
  • Grade 3 (creatinine >3-6 x ULN): Permanently discontinue
  • Grade 4 (creatinine >6 x ULN): Permanently discontinue

Rash or dermatitis

  • Consider initial dose of 1-2 mg/kg/day to 2 mg/kg/day prednisone or equivalent followed by a taper
  • Grade 2 for >1 week: Withhold dose
  • Grade 3: Withhold dose
  • Grade 4: Permanently discontinue

Infection

  • Grades 3 or 4: Withhold dose
  • Initiate symptomatic management; treat with anti-infectives for suspected or confirmed infections

Infusion-related reactions

  • Grades 1 or 2: Interrupt or slow infusion rate; consider premedication with subsequent doses
  • Grade 3 or 4: Permanently discontinue

Other

  • Grade 3
    • Withhold dose
    • Initiate symptomatic management
  • Grade 4
    • Permanently discontinue
    • Consider initial dose of 1-2 mg/kg/day to 2 mg/kg/day prednisone or equivalent followed by a taper

Dosing Considerations

Indication for urothelial carcinoma is approved under accelerated approval based on tumor response rate and duration of response; continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials

Safety and efficacy not established

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Adverse Effects

>10%

Adverse effects are for all grades unless otherwise specified Fatigue (39%) Infusion-related reactions (29.7%) Musculoskeletal pain (24%) Constipation (21%) Decreased appetite/hypophagia Nausea (16%) Peripheral edema (15%) Urinary tract infection (15%) Pyrexia/tumor associated fever (14%) Abdominal pain (14%) Dyspnea/exertional dyspnea (13%) Diarrhea/colitis (13%) Hyponatremia, grades 3-4 (12%) Lymphopenia, grades 3-4 (11%) Rash (11%)

1-10%

Adverse effects are for all grades unless otherwise specified

Cough (10%)

Anemia, grades 3-4 (8%)

Infusion-related reactions, grades 3-4 (6%)

Increased alkaline phosphatase, grades 3-4 (4%)

Hypermagnesemia, grades 3-4 (4%)

Hypercalcemia, grades 3-4 (3%)

Hyperglycemia, grades 3-4 (3%)

Immune-mediated pneumonitis or ILD (2.3%)

Increased AST, grades 3-4 (2%)

Immune-mediated hepatitis (1.1%)

Increased ALT, grades 3-4 (1%)

Hyperbilirubinemia, grades 3-4 (1%)

Increased creatinine, grades 3-4 (1%)

Neutropenia, grades 3-4 (1%)

Hyperkalemia, grades 3-4 (1%)

Hypokalemia, grades 3-4 (1%)

Hypoalbuminemia, grades 3-4 (1%)

<1%

Immune-mediated pneumonitis or ILD, grades 3-4 (0.4%)

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Warnings

Contraindications

None

Cautions

Immune-mediated pneumonitis or interstitial lung disease reported; monitor for signs and symptoms; evaluate patients with suspected pneumonitis with radiographic imaging (see Dosage Modifications)

Administer corticosteroids, prednisone 1 to 2 mg per kg per day or equivalent for moderate (Grade 2) pneumonitis or prednisone 1 to 4 mg per kg per day or equivalent for more severe (Grade 3-4) pneumonitis, followed by taper; interrupt or permanently discontinue therapy based on the severity

Immune-mediated hepatitis reported; monitor for abnormal liver tests each cycle during treatment (see Dosage Modifications)

Immune-mediated colitis or diarrhea reported; monitor for signs and symptoms (see Dosage Modifications)

Immune-mediated endocrinopathies (eg, hypothyroidism, hyperthyroidism, adrenal insufficiency, type 1 diabetes mellitus, hypophysitis, hypopituitarism) have occurred; monitor for symptoms of these conditions (see Dosage Modifications)

Rare reports of other immune-mediated adverse effects (eg, aseptic meningitis, hemolytic anemia, rash, ITP, myocarditis, myositis, nephritis, uveitis, keratitis) have occurred (see Dosage Modifications)

Severe infusion-related reactions reported; monitor for signs and symptoms and slow infusion rate or interrupt infusion if needed; if severe, withhold or permanently discontinue (see Dosage Modifications)

Can cause fetal harm (see Pregnancy)

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Pregnancy

Pregnancy

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

Human immunoglobulin G1 (IgG1) is known to cross the placental barrier; therefore, durvalumab has the potential to be transmitted from the mother to the developing fetus

In animal reproduction studies, administration of durvalumab to pregnant cynomolgus monkeys from the confirmation of pregnancy through delivery resulted in increased in premature delivery, fetal loss, and premature neonatal death

Contraception: Advise females of reproductive potential to use effective contraception during treatment and for 3 months following the last dose

Lactation

Unknown if distributed in human breast milk; human IgG1 is excreted in human milk

Durvalumab was present in the milk of lactating cynomolgus monkeys and was associated with premature neonatal death

Because of the potential for adverse reactions in breastfed infants, advise breastfeeding women not to breastfeed during treatment and for at least 3 months after the last dose

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.

more...
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Pharmacology

Mechanism of Action

Human IgG1 kappa monoclonal antibody that blocks PD-L1 binding to PD-1 and CD80, and therefore overcoming/preventing PD-L1-mediated inhibition/suppression of T-cell activation

Blockade of PD-L1/PD-1 and PD-L1/CD80 interactions releases the inhibition of immune responses, without inducing antibody dependent cell-mediated cytotoxicity

Distribution

Vd: 5.6 L

Elimination

Half-life: 17 days

Clearance: 8.24 mL/h

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Administration

IV Compatibilities

0.9% NaCl

D5W

IV Preparation

Visually inspect drug product for particulate matter and discoloration; should appear clear to opalescent, colorless to slightly yellow solution, and free from visible particles

Discard the vial if the solution is cloudy, discolored, or visible particles are observed

Do not shake the vial

Withdraw the required volume for the dose from the vial(s) and transfer into an IV bag containing 0.9% NaCl or D5W

Mix diluted solution by gentle inversion; do not shake the solution

The final concentration of the diluted solution should be between 1-15 mg/mL

Discard partially used or empty vials

Administer infusion solution immediately once prepared (also see Storage)

IV Administration

Administer diluted solution via IV infusion over 1 hr through an IV line containing a sterile, low-protein binding 0.2 or 0.22 micron inline filter

Do not coadminister other drugs through the same infusion line

Storage

Does not contain a preservative

Do not freeze

Do not shake

Unopened vial

  • Refrigerate at 2-8°C (36-46°F)
  • Store in original carton to protect from light

Diluted solution

  • Administer infusion solution immediately once prepared
  • If infusion solution is not administered immediately and needs to be stored, the total time from vial puncture to the start of the administration should not exceed the following:
  • 24 hr in a refrigerator at 2-8°C (36-46°F), or
  • 4 hr at room temperature up to 25°C (77°F)
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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.

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  • View the formulary and any restrictions for each plan.
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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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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.