crinecerfont
Crenessity
Pharmaceutical company: Neurocrine Biosciences, Inc.
Pharmacologic classification: Corticotropin-releasing factor (CRF) type 1 receptor antagonists
Therapeutic classification: endocrine-metabolic agents
AVAILABLE FORMS
Capsules: 25 mg; 50 mg; 100 mg
Oral solution: 50 mg/mL
INDICATIONS AND DOSAGES
Adjunctive treatment to glucocorticoid replacement to control androgens in classic congenital adrenal hyperplasia
Adults and children ages 4 years and older weighing 55 kg or more: 100 mg PO b.i.d. with morning and evening meals.
Children ages 4 years and older weighing 20 kg to less than 55 kg: 50 mg PO b.i.d. with morning and evening meals.
Children ages 4 years and older weighing 10 kg to less than 20 kg: 25 mg PO b.i.d. with morning and evening meals.
Adjust-a-dose: If used together with a strong CYP3A4 inducer, double both the morning and evening dose. If used together with a moderate CYP3A4 inducer, double only the evening dose.
CONTRAINDICATIONS AND CAUTIONS
- Contraindicated in patients with hypersensitivity to crinecerfont or its components.
- Hypersensitivity reactions (throat tightness, angioedema, generalized rash) may occur.
- Continue glucocorticoids upon initiation of and during treatment with crinecerfont. Don't reduce the glucocorticoid dose below that required for cortisol replacement.
- Alert: Potentially fatal or life-threatening acute adrenal insufficiency or adrenal crisis may occur in patients with underlying adrenal insufficiency on inadequate daily glucocorticoid doses, especially in situations associated with increased cortisol need such as acute illness, serious trauma, or surgical procedures.
- Dialyzable drug: Unlikely.
PREGNANCY-LACTATION-REPRODUCTION
- Studies during pregnancy are inadequate.
- If a patient is pregnant or becomes pregnant while taking crinecerfont, report the drug exposure by calling 1-855-CRNSITY (1-855-276-7489).
- There are no data on the presence of crinecerfont in human milk or its effects on the breastfed infant or on milk production. Before initiating breastfeeding, consider patient's clinical need and risk to the infant.
- Monitor breastfed infants for signs of adrenal insufficiency (weakness, decreased feeding, weight loss).
INTERACTIONS
Drug-drug. Moderate and strong 3YP3A4 inducers (rifampin, ketoconazole): May decrease crinecerfont level and efficacy. Increase crinecerfont dosage according to manufacturer's instructions.
ADVERSE REACTIONS
CNS: fatigue, headache, dizziness, suicidal ideation.
EENT: nasal congestion, epistaxis.
GI: decreased appetite, abdominal pain.
Hematologic: neutropenia.
Musculoskeletal: arthralgia, back pain, myalgia.
Reactions in bold italics are life-threatening.
Released: June 2025
Nursing Drug Handbook
© 2025 Wolters Kluwer
suzetrigine
Journavx
Pharmaceutical company: Vertex Pharmaceuticals Inc.
Pharmacologic classification: Sodium channel blockers
Therapeutic classification: Analgesics
AVAILABLE FORMS
Tablets: 50 mg
INDICATIONS AND DOSAGES
Moderate to severe acute pain
Adults: Initially, 100 mg PO. Starting 12 hours after the initial dose, 50 mg PO every 12 hours.
Adjust-a-dose: For patients taking moderate CYP3A inhibitors or with Child-Pugh Class B liver impairment, initially 100 mg PO. Starting 12 hours after the initial dose, 50 mg PO every 12 hours for doses 2, 3, and 4. Thereafter, starting 12 hours after dose 4, 50 mg PO every 24 hours.
CONTRAINDICATIONS AND CAUTIONS
- Avoid use in patients with Child-Pugh Class C liver impairment.
- Use cautiously in patients with Child-Pugh Class B liver impairment due to higher systemic exposure.
- Avoid use in patients with eGFR less than 15 mL/minute.
- The safety and effectiveness of suzetrigine has not been established in children.
- Use for the shortest duration consistent with treatment goals. Use hasn't been studied beyond 14 days.
- Dialyzable drug: Unlikely.
PREGNANCY-LACTATION-REPRODUCTION
- Studies during pregnancy are inadequate. Based on animal studies, drug may cause fetal harm.
- Patients using hormonal contraceptives containing progestins other than levonorgestrel and norethindrone should use an additional nonhormonal contraceptive or use alternative contraceptives during treatment and for 28 days after discontinuation of suzetrigine.
- It isn't known whether drug appears in human milk or how drug affects milk production or infants who are breastfed. Weigh benefit to patient against risk to infant before use.
- Drug may reversibly impact the fertility of patients of childbearing potential.
INTERACTIONS
Drug-drug. Progestins other than levonorgestrel and norethindrone: May decrease level of hormonal contraceptive. Use of nonhormonal contraception, intrauterine system or ethinyl estradiol and norethindrone or levonorgestrel during treatment and for 28 days after discontinuation of suzetrigine is recommended.
Sensitive CYP3A substrates (midazolam) or CYP3A substrates where minimal changes in levels may lead to loss of efficacy (tacrolimus, warfarin): May reduce level of CYP3A substrate which may reduce efficacy. Refer to CYP3A substrate manufacturer instructions for dosing instruction and modification when initiating or discontinuing suzetrigine.
Strong and moderate CYP3A inducers (carbamazepine, phenytoin, dexamethasone): May decrease suzetrigine and active metabolite levels and decrease their efficacy. Avoid concomitant use.
Strong or moderate CYP3A inhibitors (ketoconazole lopinavir, amiodarone, cimetidine): May increase suzetrigine and active metabolite levels and increase risk of adverse reactions. Use with strong CYP3A inhibitors is contraindicated. Reduce suzetrigine dose when used with moderate CYP3A inhibitors.
Drug-herb. St. John's wort: May decrease suzetrigine and active metabolite levels and decrease their efficacy. Discourage use together.
Drug-food. Grapefruit, grapefruit juice: May increase suzetrigine level and risk of adverse reactions. Discourage use together.
ADVERSE REACTIONS
GI: nausea, vomiting.
GU: decreased eGFR.
Metabolic: increased CK level.
Musculoskeletal: muscle spasms.
Skin: pruritis, rash.
Reactions in bold italics are life-threatening.
Released: June 2025
Nursing Drug Handbook
© 2025 Wolters Kluwer
treosulfan
Grafapex
Pharmaceutical company: Medexus Pharma, Inc.
Pharmacologic classification: Alkylating agents
Therapeutic classification: Immunosuppressants
AVAILABLE FORMS
Powder for injection: 1 g; 5 g single-dose vials
INDICATIONS AND DOSAGES
A preparative agent, in combination with fludarabine, for allogeneic hematopoietic stem cell transplantation in patients with myelodysplastic syndrome or acute myeloid leukemia
Adults and children ages 1 and older: 10 g/m2 IV infusion daily for three days beginning on Day -4 through Day -2 before stem cell transplantation. Give fludarabine 30 mg/m2 IV infusion daily on Days -6 through Day -2.
CONTRAINDICATIONS AND CAUTIONS
- Boxed Warning: Treosulfan causes severe and prolonged myelosuppression at recommended dosage. Hematopoietic stem cell transplantation is required to prevent potentially fatal complications of prolonged myelosuppression. Monitor hematologic laboratory parameters.
- Contraindicated in patients with hypersensitivity to any component of the drug product.
- Don't begin the preparative regimen without an available stem cell donor.
- Seizures have occurred in patients treated with treosulfan.
- An increase in skin disorders (rash, dermatitis) was observed when patients received sodium bicarbonate-containing hydration during treosulfan infusion.
- Alert:Treosulfan is carcinogenic and genotoxic with an increased risk of secondary malignancy. This risk is increased in patients with Fanconi anemia and other DNA breakage disorders. The safety and efficacy of treosulfan have not been established for patients with these disorders.
- Safety and effectiveness in children younger than 1 year haven't been established.
- Dialyzable drug: Unlikely.
- Overdose S&S: Severe myelosuppression and prolonged pancytopenia, mucositis, skin toxicity, nausea, vomiting, gastritis.
PREGNANCY-LACTATION-REPRODUCTION
- May cause fetal harm; drug is genotoxic and affects dividing cells. Advise patients of fetal risk.
- Patients of childbearing potential should use effective contraception during treatment and for 6 months following the last dose.
- Male patients with partners of childbearing potential should use effective contraception during treatment and for 3 months after the last dose.
- It's unknown if treosulfan or its metabolites are excreted in human milk, the effects on the breastfed child, or on milk production. Because of the potential for serious adverse reactions in breastfed children, breastfeeding isn't recommended during treatment with treosulfan and for 1 week after the last dose.
- May cause temporary or permanent infertility.
INTERACTIONS
Drug-drug. CYP2C19 substrates (midazolam, quinidine, sirolimus) or CYP3A4 substrates (phenytoin, warfarin) where minimal changes in levels may lead to toxicity: May increase level of substrates and cause serious or life-threatening toxicity. Monitor patient closely.
ADVERSE REACTIONS
CNS: fever, headache, fatigue, insomnia, confusion, agitation, paresthesia, dizziness, pain.
CV: edema, HTN, hypotension, hemorrhage, tachycardia, HF, pericardial effusion, flushing, embolism.
EENT: pharyngeal/laryngeal inflammation, oropharyngeal pain, dysphonia, oral pain, dry mouth, vertigo.
GI: stomatitis, nausea, vomiting, diarrhea, abdominal pain, constipation, gastritis, dyspepsia, dysphagia, abdominal distension, decreased appetite.
GU: increased creatinine, AKI, hematuria, urinary tract pain.
Hematologic: febrile neutropenia, neutropenia, anemia, thrombocytopenia.
Hepatic: increased LFTs, liver toxicity.
Metabolic: decreased or increased weight, impaired glucose tolerance.
Musculoskeletal: pain.
Respiratory: pneumonitis, pleural effusion, dyspnea, cough, hiccups.
Skin: rash, dermatitis, hand-foot syndrome, pruritus, erythema, dermatitis, skin hyperpigmentation, dry skin.
Other: secondary malignancies, benign neoplasms, infection, chills, injection site reactions.
Reactions in bold italics are life-threatening.
Released: June 2025
Nursing Drug Handbook
© 2025 Wolters Kluwer
vanzacaftor, tezacaftor, and deutivacaftor
Alyftrek
Pharmaceutical company: Vertex Pharmaceuticals Inc.
Pharmacologic classification: Cystic fibrosis transmembrane regulator protein
Therapeutic classification: Miscellaneous respiratory drugs
AVAILABLE FORMS
Tablets: vanzacaftor 4 mg, tezacaftor 20 mg, and deutivacaftor 50 mg; vanzacaftor 10 mg, tezacaftor 50 mg, and deutivacaftor 125 mg
INDICATIONS AND DOSAGES
Cystic fibrosis in patients who have at least one responsive mutation in the CFTR gene
Adults and children ages 12 and older: Two tablets of vanzacaftor 10 mg/tezacaftor 50 mg/deutivacaftor 125 mg PO once daily.
Children ages 6 to less than 12 years weighing 40 kg or more: Two tablets of vanzacaftor 10 mg/tezacaftor 50 mg/deutivacaftor 125 mg PO once daily.
Children ages 6 to less than 12 years weighing less than 40 kg: Three tablets of vanzacaftor 4 mg/tezacaftor 20 mg/deutivacaftor 50 mg PO once daily.
Adjust-a-dose: Refer to manufacturer's instructions for administration with strong or moderate CYP3A inhibitors.
CONTRAINDICATIONS AND CAUTIONS
- Boxed Warning: Elevated transaminases have been observed. Serious and potentially fatal drug-induced liver injury and liver failure were reported in patients taking a drug containing elexacaftor, tezacaftor, and ivacaftor, which contains the same or similar active ingredients as vanzacaftor, tezacaftor, and deutivacaftor. Liver injury has been reported within the first month of therapy and up to 15 months following initiation of elexacaftor/tezacaftor/ivacaftor.
- Boxed Warning: Vanzacaftor, tezacaftor, and deutivacaftor shouldn't be used in patients with Child-Pugh Class C liver impairment. Use isn't recommended in patients with Child-Pugh Class B liver impairment and should only be considered when there is a clear medical need, and the benefit outweighs the risk. If used, monitor patients closely.
- Use in patients with eGFR less than 30L/minute/1.73 m2 only if benefits outweigh risks.
- Hypersensitivity reactions, including anaphylaxis, have been reported with drugs containing elexacaftor, tezacaftor or ivacaftor.
- Non-congenital lens opacities have been reported in children treated with drugs containing ivacaftor (a CFTR protein). Baseline and follow-up ophthalmological examinations are recommended.
- Safety and effectiveness of Alyftrek in children younger than 6 years of age have not been established.
- Dialyzable drug: Unknown.
PREGNANCY-LACTATION-REPRODUCTION
- Studies during pregnancy are inadequate. It isn't known if drug will cause fetal harm.
- There are no data on the presence of vanzacaftor, tezacaftor, or deutivacaftor or their metabolites in human milk, the effects on the breastfed infant, or the effects on milk production. It is likely that the drug is present in human milk. Consider benefits of breastfeeding with the clinical needs of the patient and potential adverse effects in the infant.
INTERACTIONS
Drug-drug. BCRP substrates (cimetidine, glyburide, prazosin) CYP2C9 substrates (losartan, ibuprofen), P-gp substrates (apixaban, digoxin, tacrolimus): May increase substrate level and risk of substrate-related adverse reactions. Monitor for substrate-related adverse reactions.
Strong or moderate CYP3A inducers (carbamazepine, phenytoin, rifampin): May decrease levels of vanzacaftor, tezacaftor, and deutivacaftor and reduce effectiveness. Use together isn't recommended.
Strong or moderate CYP3A inhibitors (erythromycin, ketoconazole, imatinib): May increase levels of vanzacaftor, tezacaftor, and deutivacaftor and the risk of adverse reactions. If use together can't be avoided, reduce the dose of vanzacaftor, tezacaftor, and deutivacaftor per manufacturer recommendations.
Warfarin: May increase warfarin level. Monitor INR more frequently.
Drug-food. Grapefruit, grapefruit juice: May increase level of vanzacaftor, tezacaftor and deutivacaftor and increase the risk of adverse reactions. Discourage use together.
ADVERSE REACTIONS
CNS: headache, fatigue.
CV: increased BP.
EENT: cataracts, nasopharyngitis, oropharyngeal pain, sinus congestion.
Hepatic: increased transaminase levels.
Metabolic: increased CK level.
Respiratory: cough, URI.
Skin: rash.
Other: flu-like symptoms.
Reactions in bold italics are life-threatening.
Released: June 2025
Nursing Drug Handbook
© 2025 Wolters Kluwer