Names and pronunciation
(seh-mip′lih-mab) Libtayo
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Drug reference
(seh-mip′lih-mab) Libtayo
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Func. class.: Antineoplastic— monoclonal antibody
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Chem. class.: Programmed death receptor-1 (PD-1)/PD-L1
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ACTION: Binds to the programmed death receptor-1 (PD-1) found on T cells. Blocking the PD-1/PD-L1 pathway improves the antitumor immune response by reducing immunosuppres- sive signals
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USES: Squamous cell skin carcinoma in patients who are not candidates for curative surgery/radiation
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CONTRAINDICATIONS: Hyper- sensitivity, pregnancy, breastfeeding Precautions: Adrenal insufficiency, autoimmune disease, colitis, contracep- tion requirements, Crohn’s disease, hepatitis, hyperthyroidism, immune- mediated reactions, infusion-related reactions, organ transplant, pneumoni- tis, pregnancy testing, renal impair- ment, reproductive risk, serious rash, type 1 diabetes mellitus, ulcerative colitis
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SIDE EFFECTS CNS: Fatigue, asthenia EENT: Immune-mediated optic nephritis ENDO: Immune-mediated hypophysitis, immune-mediated hypothyroidism/ hyperthyroidism, immune-mediated type 1 diabetes mellitus GI: Anorexia, nausea, vomiting, abdomi- nal pain, constipation, diarrhea, immune- mediated colitis, immune-mediated hepatitis GU: Immune-mediated nephritis HEMA: Anemia INTEG: Rash, pruritus, infusion-related reactions MS: Immune-mediated rhabdomyolysis, back pain, myalgia, MS pain RESP: Immune-mediated pneumonitis
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DOSAGE AND ROUTES • Adult: IV 350 mg over 30 min q3wk until disease progression
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Available forms: Injection 350 mg/7 mL (50 mg/mL) single-dose vial Administer IV INFUSION route • Visually inspect for particulate matter and discoloration before use; product is clear to slightly opalescent, colorless to pale yellow and may contain trace amounts of translucent to white particles • Do not shake vial Dilution: • Withdraw 7 mL and dilute with normal saline or D5W (1 mg/mL to 20 mg/mL) mix by gentle inversion, do not shake • Discard any unused portion • Storage: Store unopened vial in refrigera- tor, protect from light, store at room tem- perature (up to 77°F [25°C]) for up to 8 hr or refrigerated (36-46°F [2-8°C]) for up to 24 hr from time of dilution. Do not freeze • If refrigerated, allow to warm to room temperature • Give diluted solution over 30 min through a sterile, in-line or add-on 0.2- to 0.5-micron filter
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Assess: • Immune-mediated pneumoni- tis: shortness of breath, chest pain, new or worsening cough periodically; if present, obtain x-ray; withhold until grade ≤1; usually treated with corticosteroids • Immune-mediated colitis: se- vere diarrhea or abdominal pain, blood or mucus in stool. Therapy may need to be interrupted or discontinued based on severity; corticosteroids may be used; permanently discontinue if grade 4 tox- icity • Immune-mediated hepatitis: jaundice of skin/eyes, severe nausea/ vomiting; obtain liver function tests prior to starting and periodically during therapy; if hepatitis occurs, therapy may need to be interrupted or discontinued based on se- verity of the toxicity; corticosteroids may be given • Infusion-related reactions: fe- ver, pruritus, wheezing, rigors; if severe grade 3 or 4, discontinue permanently • Immune-mediated dermato- logic reactions: erythema multiforme, Stevens-Johnson syndrome, toxic epider- mal necrolysis have occurred with similar products; interrupt or discontinue in pa- tients who develop severe skin toxicity; provide corticosteroids followed by a 1-mo taper, starting when the toxicity re- solves to grade ≤1 • Immune-mediated hypophysi- tis: continual headache, weakness, fa- tigue, blurred vision, dizziness; provide corticosteroids for grade 2; if severe (grade 3), withhold or discontinue until toxicity resolves to grade ≤1; perma- nently discontinue for grade 4 • Immune-mediated nephritis: monitor serum creatinine and BUN baseline and periodically; corticoste- roids may be used for grade ≥2 nephri- tis; withhold for grade 2, resume when recovery is grade ≤1; discontinue for grade 4 • Blood glucose baseline and periodi- cally; may cause hyperglycemia • Thyroid function test baseline and pe- riodically; may cause hypo/hyperthyroid- ism; corticosteroids may be used for grade 3 hypothyroidism; withhold prod- uct for severe grade 3, permanently dis- continue for grade 4 • Pregnancy/breastfeeding: product should not be used in pregnancy and for 4 mo after last dose or breastfeeding and for 4 mo after last dose; perform preg- nancy test in all women of childbearing potential EVALUATE: • Therapeutic response: decreased spread of skin cancer Teach patient/family • That product treats a type of skin cancer by working with your immune system • To notify prescriber immediately of new or worsening cough, shortness of breath, chest pain, diarrhea; stools that are black, tarry, sticky, or have blood or mucus; abdominal pain, yellowing of skin/eyes, severe nausea/vomiting, bleeding or bruising more easily, unusual headaches, rapid heartbeat, increased sweating, extreme tiredness, weight gain/weight loss, dizziness/fainting, feeling hungrier or thirstier than usual, hair loss, feeling cold, constipation, skin rash with blisters • To inform health care provider of all Rx, OTC, vitamins, and herbal products taken and not to take others without prescriber’s approval • That blood work and regular exams will be needed throughout treatment • Pregnancy/breastfeeding: to inform health care provider if pregnancy is planned or suspected. That product should not be used in pregnancy or breastfeeding. That a pregnancy test is required before treatment begins and that a nonhormonal form of contraception will be needed to prevent pregnancy during treatment and for 4 mo after treatment ends. Not to breastfeed during treatment or for 4 mo after last dose See cephalosporins—first generation CEPHALOSPORINS— FIRST GENERATION
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CLINICAL CONSIDERATIONS
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PHARMACOKINETICS Onset, peak, duration unknown; half-life 19 days Interaction: None known
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• Adult: IV 350 mg over 30 min q3wk until disease progression
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