atezolizumab (Rx)

Brand and Other Names:Tecentriq
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

IV solution

  • 1200mg/20mL (60mg/mL)

Urothelial Carcinoma

Indicated for locally advanced or metastatic urothelial carcinoma in patients who are not eligible for cisplatin-containing chemotherapy, or have disease progression during or following platinum-containing chemotherapy, or disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy

1200 mg IV q3wk infused over 60 min until disease progression or unacceptable toxicity

If the first infusion is tolerated, all subsequent infusions may be administered IV over 30 min

See Administration

Non-Small Cell Lung Cancer

Indicated for patients with metastatic non-small cell lung cancer (NSCLC) who have disease progression during or following platinum-containing chemotherapy; patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving atezolizumab

1200 mg IV q3wk infused over 60 min until disease progression or unacceptable toxicity

If the first infusion is tolerated, all subsequent infusions may be administered IV over 30 min

See Administration

Dosage Modifications

No dose reductions are recommended

Withhold dose for any of the following:

  • AST or ALT >3 and up to 5 x ULN, or total bilirubin >1.5 and up to 3 x ULN
  • Grade 2 or 3 diarrhea or colitis
  • Symptomatic hypophysitis, adrenal insufficiency, hypothyroidism, hyperthyroidism, or grade 3 or 4 hyperglycemia
  • Grade 2 ocular inflammatory toxicity
  • Grade 2 or 3 pancreatitis or grade 3 or 4 increases in amylase or lipase levels (ie, >2 x ULN)
  • Grade 3 or 4 infection
  • Grade 2 infusion-related reactions
  • Grade 3 rash
  • May resume dosing in patients whose adverse reactions recover to grade 0-1

Permanently discontinue

  • Grade 3 or 4 pneumonitis
  • AST or ALT >5 x ULN or total bilirubin >3 x ULN
  • Grade 4 diarrhea or colitis
  • Grade 4 hypophysitis
  • Myasthenic syndrome/myasthenia gravis, Guillain-Barré, or meningoencephalitis
  • Grade 3 or 4 ocular inflammatory toxicity
  • Grade 4 or any grade of recurrent pancreatitis
  • Grade 3 or 4 infusion-related reactions
  • Grade 4 rash

Renal impairment

  • No dose adjustment is recommended

Hepatic impairment

  • Mild: No dose adjustment is recommended
  • Moderate-to-severe: Not studied

Dosing Considerations

Approved under accelerated approval based on tumor response rate and durability of response

Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials

Ventana PD-L1 is a complementary diagnostic assay to provide PD-L1 status on patients who are considering treatment with atezolizumab

Small Cell Lung Cancer (Orphan)

Orphan designation for treatment of small cell lung cancer

Sponsor

  • Genentech, Inc; 1 DNA Way; South San Francisco, California 94080

Melanoma (Orphan)

Orphan designation (with or without cobimetinib) for treatment of stage IIb, IIc, III, and IV melanoma

Sponsor

  • Genentech, Inc; 1 DNA Way, MS 35-5E; South San Francisco, California 94080

Safety and efficacy not established

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Adverse Effects

>10%

All grades unless otherwise stated

Fatigue (52%)

Decreased appetite (26%)

Nausea (25%)

Urinary tract infection (22%)

Constipation (21%)

Pyrexia (21%)

Diarrhea (18%)

Peripheral edema (18%)

Abdominal pain (17%)

Vomiting (17%)

Dyspnea (16%)

Back/neck pain (15%)

Rash (15%)

Arthralgia (14%)

Pruritus (13%)

1-10%

All are grades 3-4

Lymphopenia (10%)

Hyponatremia (10%)

Anemia (8%)

Hyperglycemia (5%)

Increased alkaline phosphatase (4%)

Increased creatinine (3%)

Increased ALT (2%)

Increased AST (2%)

Hypoalbuminemia (1%)

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Warnings

Contraindications

None

Cautions

Withhold for moderate and permanently discontinue for severe or life-threatening pneumonitis

Monitor for changes in liver function; withhold for moderate and permanently discontinue for severe or life-threatening transaminase or total bilirubin elevation

Withhold for moderate or severe, and permanently discontinue for life-threatening colitis

Immune-related myasthenic syndrome/myasthenia gravis, Guillain Barré, or meningoencephalitis: Permanently discontinue for any grade

Withhold for moderate and permanently discontinue for severe ocular inflammatory toxicity

Withhold for moderate or severe, and permanently discontinue for life-threatening pancreatitis, or any grade of recurring pancreatitis

Withhold for severe or life-threatening infection

Interrupt or slow the rate of infusion for mild or moderate infusion reactions and discontinue for severe or life-threatening infusion reactions

Can cause fetal harm; advise females of reproductive potential of the potential risk to a fetus and use of effective contraception

Immune-related endocrinopathies

  • Hypophysitis: Withhold for moderate or severe and permanently discontinue for life-threatening hypophysitis
  • Thyroid disorders: Monitor for changes in thyroid function; withhold for symptomatic thyroid disease
  • Adrenal insufficiency: Withhold for symptomatic adrenal insufficiency
  • Type 1 diabetes mellitus: Withhold for ≥grade 3 hyperglycemia
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Pregnancy

Pregnancy

Based on its mechanism of action, can cause fetal harm when administered during pregnancy; advise females of reproductive potential to use effective contraception during treatment and for at least 5 months following the last dose

Based on animal studies, atezolizumab may impair fertility in females of reproductive potential while receiving treatment

Lactation

Unknown if distributed in human breast milk

Advise lactating woman not to breastfeed during treatment and for at least 5 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.

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Pharmacology

Mechanism of Action

Monoclonal antibody to programmed cell death ligand-1 protein (PDL1); binding PDL1 blocks the interaction between PDL-1 and its ligands (including B7.1 receptors)

PDL-1

  • PDL1 is expressed on the surface of activated T cells under normal conditions; binding PDL1 inhibits immune activation and reduces T-cell cytotoxic activity when bound
  • This negative feedback loop is essential for maintaining normal immune responses and limits T-cell activity to protect normal cells during chronic inflammation
  • Tumor cells may circumvent T-cell–mediated cytotoxicity by expressing PDL1 on the tumor itself or on tumor-infiltrating immune cells, resulting in the inhibition of immune-mediated killing of tumor cells

Absorption

Systemic accumulation over 2-3 cycles of repeated dosing

  • Peak plasma concentration: 1.91-fold
  • Minimum plasma concentration: 1.46-fold
  • AUC: 2.75-fold

Distribution

Vd: 6.9 L

Elimination

Half-life: 27 days

Clearance: 0.2 L/day

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Administration

IV Preparation

Visually inspect drug product for particulate matter and discoloration prior to administration

Solution should appear colorless to slightly yellow

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

Do NOT shake the vial

Dilution

  • Withdraw 20 mL of solution from the vial
  • Dilute into a 250-mL polyvinyl chloride (PVC), polyethylene (PE), or polyolefin (PO) infusion bag containing 0.9% NaCl
  • Dilute with 0.9% NaCl only
  • Mix diluted solution by gentle inversion; do not shake
  • Discard partially used or empty vial

IV Administration

For IV infusion only; do not give as IV bolus or IV push

Administer through an IV line with or without a sterile, nonpyrogenic, low-protein binding in-line filter (pore size of 0.2–0.22 micron)

First IV infusion: Infuse over 60 min

Subsequent IV infusions: If first infusion is tolerated, may administer subsequent doses over 30 min

Do not coadminister with other drugs through the same IV line

Storage

Contains no preservatives

Do not freeze undiluted or diluted solution

Do not shake undiluted or diluted solution

Unopened vials

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

Diluted infusion solution

  • Administer immediately once prepared
  • If not used immediately, it can be stored by either:
    • At room temperature for <6 hr from time of preparation (includes infusion time) OR
    • Refrigerate at 2-8°C (36-46°F) for no more than 24 hr
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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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