KEMSTRO
Clinical safety rating: caution
Comprehensive clinical and safety monograph for KEMSTRO (KEMSTRO).
KEMSTRO (corticorelin acetate) is a synthetic form of corticotropin-releasing factor (CRF) that stimulates the pituitary gland to release adrenocorticotropic hormone (ACTH), thereby increasing cortisol production. It also binds to CRF receptors in the brain, which may reduce cerebral edema by stabilizing the blood-brain barrier and modulating inflammatory responses.
| Metabolism | Corticorelin acetate is primarily metabolized by peptidases and proteases in plasma and tissues. No specific cytochrome P450 involvement. |
| Excretion | Renal: 80% unchanged; fecal: 15% as metabolites; biliary: <5% |
| Half-life | Terminal elimination half-life: 12-16 hours (prolonged in renal impairment, e.g., up to 30 hours with CrCl <30 mL/min) |
| Protein binding | 95% (primarily to albumin) |
| Volume of Distribution | 0.3-0.5 L/kg (reflects moderate tissue distribution; higher in obesity) |
| Bioavailability | Oral: 60% (with first-pass metabolism); IM: 85% |
| Onset of Action | IV: 2-5 minutes; Oral: 30-60 minutes |
| Duration of Action | IV: 4-6 hours (clinical effect); Oral: 6-8 hours (dose-dependent) |
| Molecular Weight | 413.55 Da |
KEMSTRO (pembrolizumab) 200 mg intravenously every 3 weeks or 400 mg intravenously every 6 weeks.
| Dosage form | TABLET, ORALLY DISINTEGRATING |
| Renal impairment | No dose adjustment required for mild to moderate renal impairment (CrCl ≥30 mL/min). Insufficient data for severe impairment (CrCl <30 mL/min); use with caution. |
| Liver impairment | For Child-Pugh A: no adjustment. Child-Pugh B: no adjustment recommended; use with caution. Child-Pugh C: not recommended due to lack of data. |
| Pediatric use | For pediatric patients (≥3 years) with relapsed/refractory classical Hodgkin lymphoma: 2 mg/kg (maximum 200 mg) intravenously every 3 weeks. |
| Geriatric use | No specific dose adjustment recommended for patients ≥65 years; monitor for adverse events due to potential age-related decline in organ function. |
| 1st trimester | Contraindicated due to risk of teratogenicity. |
| 2nd trimester | Contraindicated due to risk of fetal harm. |
| 3rd trimester | Contraindicated due to risk of fetal harm and neonatal toxicity. |
Clinical note
Comprehensive clinical and safety monograph for KEMSTRO (KEMSTRO).
| Placental transfer | Extensive placental transfer documented in animal studies; likely human transfer. |
| Breastfeeding | Not recommended during breastfeeding due to potential excretion in milk and risk of infant toxicity. |
| Lactation Rating | L5 (Contraindicated) |
■ FDA Black Box Warning
None.
| Serious Effects |
PregnancyBreastfeedingHypersensitivity to KEMSTRO or its excipients
| Precautions | May cause hypercortisolism including Cushing's syndrome with prolonged use, Adrenal suppression may occur, requiring gradual taper upon discontinuation, May mask signs of infection due to immunosuppressive effects, Use with caution in patients with diabetes, hypertension, or osteoporosis |
| Food/Dietary | Avoid alcohol; may increase risk of GI bleeding. Can be taken with food or milk to reduce gastrointestinal irritation. No specific food restrictions. |
| Clinical Pearls |
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| Teratogenic Risk | KEMSTRO (carisbamate) is classified as Pregnancy Category C. First trimester: Adequate animal reproduction studies have not been conducted; potential for teratogenicity is unknown. Second and third trimesters: Risk cannot be ruled out; use only if potential benefit justifies risk. There are no adequate and well-controlled studies in pregnant women. |
| Fetal Monitoring | Monitor fetal growth and development via ultrasound. Assess for signs of adverse effects in the neonate after delivery, including sedation, poor feeding, or respiratory depression. Periodic liver function tests and complete blood counts are recommended. |
| Fertility Effects | Animal studies with carisbamate have not revealed impaired fertility. Effects on human fertility are unknown. |
| KEMSTRO (ketorolac tromethamine) is an NSAID for short-term (≤5 days) management of moderate-to-severe acute pain. Do not use for minor or chronic pain. Contraindicated in active peptic ulcer disease, renal impairment (CrCl <30 mL/min), bleeding diathesis, or concomitant anticoagulation. Monitor renal function and GI symptoms. Maximum daily dose: 120 mg IM/IV or 40 mg oral. Use with caution in elderly and patients with dehydration. |
| Patient Advice | Use only for short-term pain relief (up to 5 days). · Take with food or milk to reduce stomach upset. · Avoid alcohol and other NSAIDs (e.g., ibuprofen, aspirin) while on this medication. · Report signs of bleeding (bruising, black stools), stomach pain, or kidney issues (swelling, decreased urination). · Do not drive if you experience dizziness or drowsiness. |