registration code [1:ULN and AST > ULN or bilirubin 1 to 1.5 times ULN and any AST): There are no dosage adjustments provided in the manufacturer's labeling (has not been studied). Hepatotoxicity during treatment: AST or ALT >3 to 5 times ULN or total bilirubin >1.5 to 3 times ULN: Withhold treatment. AST or ALT >5 times ULN or total bilirubin >3 times ULN: Discontinue permanently. Immune-mediated hepatitis: Grade 2 or greater transaminase elevations (with or without total bilirubin elevations): Withhold treatment and initiate high-dose systemic corticosteroids (prednisone 1 to 2 mg/kg daily or equivalent, followed by a taper) Severe (grade 3) or life-threatening (grade 4): Permanently discontinue treatment and initiate high-dose systemic corticosteroids (prednisone 1 to 2 mg/kg daily or equivalent, followed by a taper) Dosing: Adjustment for Toxicity Dosage reductions are not recommended for toxicities. Treatment is withheld or permanently discontinued. If therapy is withheld, may resume if toxicity recovers to grade 0 or 1. Dermatologic toxicity: Rash, grade 3: Withhold treatment. Rash, grade 4: Discontinue permanently. Endocrinopathies: Adrenal insufficiency (symptomatic): Withhold treatment. Administer IV methylprednisolone 1 to 2 mg/kg/day and convert to oral prednisone 1 to 2 mg/kg/day or equivalent upon improvement in symptoms. When symptoms improve to grade 1 or lower, begin to taper steroids over at least 1 month. Resume atezolizumab treatment if symptoms improve to grade 0 or 1 within 12 weeks, and corticosteroids have been reduced to oral prednisone 10 mg/day (or equivalent) and patient is stable on adrenal replacement therapy (if needed). Hyperglycemia, grade 3 or 4: Withhold treatment. May require insulin treatment. Hyperthyroidism or hypothyroidism: Withhold treatment. May require additional treatment for symptomatic hypo- or hyperthyroidism. Hypophysitis (symptomatic): Withhold treatment. Administer corticosteroids and hormone replacement as clinically necessary. Hypophysitis, grade 4: Discontinue permanently. Administer corticosteroids and hormone replacement as clinically necessary. Gastrointestinal toxicity: Amylase or lipase elevations, grade 3 or 4 (>2 times ULN): Withhold treatment. Administer IV methylprednisolone 1 to 2 mg/kg/day and convert to oral corticosteroids (prednisone 1 to 2 mg/kg/day or equivalent) upon improvement in symptoms. Resume atezolizumab if amylase and lipase levels improve to grade 1 or lower within 12 weeks and corticosteroids have been reduced to oral prednisone 10 mg/day (or equivalent). Diarrhea or colitis, grade 2 or 3: Withhold treatment. For grade 2 diarrhea or colitis, if symptoms persist for >5 days or recur, administer systemic corticosteroids (1 to 2 mg/kg/day prednisone or equivalent). For grade 3 diarrhea or colitis, administer IV methylprednisolone 1 to 2 mg/kg/day and convert to oral corticosteroids upon improvement in symptoms. If grade 2 and 3 symptoms improve to grade 0 or 1, taper corticosteroids over at least 1 month. Resume atezolizumab treatment if improves to grade 0 or 1 within 12 weeks and corticosteroids have been reduced to oral prednisone 10 mg/day (or equivalent). Diarrhea or colitis, grade 4: Discontinue permanently. Administer IV methylprednisolone 1 to 2 mg/kg/day and convert to oral corticosteroids upon improvement in symptoms. Pancreatitis, grade 2 or 3: Withhold treatment. Administer IV methylprednisolone 1 to 2 mg/kg/day and convert to oral corticosteroids (prednisone 1 to 2 mg/kg/day or equivalent) upon improvement in symptoms. Resume atezolizumab if pancreatitis symptoms have resolved and corticosteroids have been reduced to oral prednisone 10 mg/day (or equivalent). Pancreatitis, grade 4: Discontinue permanently. Administer IV methylprednisolone 1 to 2 mg/kg/day and convert to oral corticosteroids (prednisone 1 to 2 mg/kg/day or equivalent) upon improvement in symptoms. Pancreatitis, recurrent (any grade): Discontinue permanently. Administer IV methylprednisolone 1 to 2 mg/kg/day and convert to oral corticosteroids (prednisone 1 to 2 mg/kg/day or equivalent) upon improvement in symptoms. Myocarditis (any grade): Discontinue permanently; may require systemic corticosteroids and/or other immunosuppressant therapy as clinically indicated (Perez 2017). Ophthalmic disorders: Ocular inflammatory toxicity, grade 2: Withhold treatment. Ocular inflammatory toxicity, grade 3 or 4: Discontinue permanently. Pulmonary toxicities: Pneumonitis, grade 2: Withhold treatment. Administer high-dose systemic corticosteroids (prednisone 1 to 2 mg/kg daily or equivalent) followed by a corticosteroid taper. Pneumonitis, grade 3 or 4: Discontinue permanently. Administer high-dose systemic corticosteroids (prednisone 1 to 2 mg/kg daily or equivalent) followed by a corticosteroid taper. Other/miscellaneous toxicities: Guillain-Barre, any grade: Discontinue permanently. Infection, grade 3 or 4: Withhold treatment. Infusion-related reactions, grade 2 or mild to moderate: Withhold treatment or slow the rate of infusion. Infusion-related reactions, grade 3 or 4: Discontinue permanently. Meningoencephalitis, any grade: Discontinue permanently. Administer IV corticosteroids (methylprednisolone 1 to 2 mg/kg/day) and convert to oral therapy (prednisone 60 mg/day or equivalent) upon improvement; when symptoms improve to grade 1 or lower, taper corticosteroids over at least 1 month. Myasthenic syndrome/myasthenia gravis: Discontinue permanently. Consider systemic corticosteroids (prednisone 1 to 2 mg/kg/day). Reconstitution Withdraw 1,200 mg (20 mL) from vial and dilute into 250 mL of NS in a polyvinyl chloride (PVC), polyethylene (PE), or polyolefin (PO) infusion bag. Dilute only with NS. Mix by gently inverting; do not shake. Administration IV: Infuse the initial dose over 60 minutes, if tolerated, may infuse subsequent doses over 30 minutes. May be infused with or without a 0.2- to 0.22-micron sterile, non-pyrogenic, low-protein binding in-line filter. Do not administer as an IV push or bolus. Do not administer other medications at the same time through the same IV line. Monitor for infusion reactions. Storage Store intact vials at 2 C to 8 C (36 F to 46 F). Do not freeze. Do not shake. Store in original carton to protect from light. Solutions diluted in NS for infusion should be used immediately after preparation; if not used immediately, may be stored for up to 6 hours (including administration time) at room temperature or 24 hours refrigerated at 2 C to 8 C (36 F to 46 F). Do not freeze. Drug Interactions Belimumab: Monoclonal Antibodies may enhance the adverse/toxic effect of Belimumab. Avoid combination Adverse Reactions >10%: Cardiovascular: Peripheral edema (18%) Central nervous system: Fatigue (52%), insomnia (NSCLC: 14%) Dermatologic: Skin rash (15%), pruritus (13%) Endocrine & metabolic: Hypoalbuminemia (NSCLC: 48%), hyponatremia (NSCLC: 48%), hypokalemia (NSCLC: 18%), hypercalcemia (NSCLC: 13%) Gastrointestinal: Decreased appetite (26%), nausea (25%), constipation (21%), colitis (19% to 20%), diarrhea (18% to 20%), abdominal pain (17%), vomiting (17%) Genitourinary: Urinary tract infection (22%), hematuria (14%) Hematologic & oncologic: Lymphocytopenia Hepatic: Increased serum alkaline phosphatase (NSCLC: 42%), increased serum AST (NSCLC: 33%), increased serum ALT (NSCLC: 31%), increased serum bilirubin (NSCLC: 11%) Immunologic: Antibody development (42%; no clinically significant impact on pharmacokinetics, safety, or efficacy) Infection: Infection (38%) Neuromuscular & skeletal: Musculoskeletal pain (NSCLC: 22%), back pain ( 15%), neck pain ( 15%), arthralgia (14%) Renal: Increased serum creatinine (NSCLC: 19%) Respiratory: Pneumonia (NSCLC: 18%), dyspnea (16%), cough (14%) Miscellaneous: Fever (21%) 1% to 10%: Cardiovascular: Venous thromboembolism Central nervous system: Guillain-Barre syndrome ( 1%), meningoencephalitis ( 1%), myasthenia ( 1%), myasthenia gravis ( 1%), confusion Endocrine & metabolic: Hypothyroidism (3% to 4%), hyperthyroidism ( 1%), hyperglycemia Gastrointestinal: Increased serum amylase ( 1%), increased serum lipase ( 1%), pancreatitis ( 1%), dysphagia (NSCLC), intestinal obstruction Genitourinary: Urinary tract obstruction Hematologic & oncologic: Anemia Hepatic: Hepatitis ( 1%) Infection: Sepsis Ophthalmic: Intraocular inflammation ( 1%) Renal: Acute renal failure Respiratory: Pneumonitis ( 4%), pleural effusion (NSCLC: >2%), hypoxia (NSCLC) Miscellaneous: Infusion related reaction (severe: 1% to 2%)]} Recently Approved Lonhala Magnair Lonhala Magnair (glycopyrrolate) is a long-acting muscarinic antagonist (LAMA) bronchodilator for... 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