atrasentan
Vanrafia
Pharmaceutical company: Novartis Pharmaceuticals
Pharmacologic classification: Endothelin receptor antagonists
Therapeutic classification: Miscellaneous GU drugs
AVAILABLE FORMS
Tablets: 0.75 mg
INDICATIONS AND DOSAGES
To reduce proteinuria in adults with primary IgA nephropathy at risk of rapid disease progression, a urine protein-to-creatinine ratio greater than or equal to 1.5 g/g
Adults: 0.75 mg PO daily.
ADVERSE REACTIONS
CV: decreased BP, peripheral edema.
Hematologic: anemia.
Hepatic: increased transaminase levels.
INTERACTIONS
Drug-drug. Moderate or strong CYP3A inducers (carbamazepine, phenytoin, rifampin): May decrease atrasentan level and efficacy. Avoid use together.
OATP1B1/1B3 inhibitors (lopinavir, lovastatin, ritonavir, simvastatin): May increase atrasentan level and risk of adverse reactions. Avoid use together.
Drug-herb. St. John's wort: May decrease atrasentan level. Discourage use together.
CONTRAINDICATIONS AND CAUTIONS
- Contraindicated in patients with a history of hypersensitivity to drug or its components.
- Contraindicated in patients with Child-Pugh class C liver impairment. Drug increases risk of liver toxicity.
- Use cautiously in patients with HF. Drug may cause fluid retention.
- Safety and effectiveness in children haven't been established.
- Dialyzable drug: Unlikely.
PREGNANCY-LACTATION-REPRODUCTION
- Boxed Warning: Contraindicated in pregnancy. Drug may cause major birth defects. Effective contraception should be used before, during therapy, and for 2 weeks after final dose.
- It's unknown whether drug is present in human milk. Due to risk for adverse effects, breastfeeding isn't recommended during therapy.
- Drug may decrease spermatogenesis.
Reactions in bold italics are
life-threatening.
Released: August 2025
Nursing Drug Handbook
© 2025 Wolters Kluwer
fitusiran
Qfitlia
Pharmaceutical company: Genzyme Corporation
Pharmacologic classification: Antithrombin-directed small interfering RNA agent
Therapeutic classification: Miscellaneous hematologic drugs
AVAILABLE FORMS
Injection: 20 mg/0.2 mL single-dose vials; 50 mg/0.5 mL single-dose prefilled pens
INDICATIONS AND DOSAGES
Routine prophylaxis for the prevention or reduction of bleeding episodes from hemophilia A or B, with or without factor VIII or factor IX inhibitors
Adults and children age 12 and older: Initially, 50 mg subcut once every 2 months. Adjust dose or dosing interval as needed to maintain antithrombin (AT) activity at 15 to 35%.
Adjust-a-dose: If AT activity is less than 15%, reduce dosage 3 months after the prior dose; if AT activity is greater than 35% after 6 months or bleed control hasn't been achieved, consider dosage increase. Refer to manufacturer's instructions for dose modifications based on AT activity levels and breakthrough bleed management.
ADVERSE REACTIONS
CNS: headache.
CV: thrombotic event.
EENT: nasopharyngitis.
GI: abdominal pain, gall bladder disease, dyspepsia.
Hepatic: liver toxicity.
Musculoskeletal: arthralgia.
Respiratory: cough.
Skin: injection site reaction.
Other: viral or bacterial infection.
INTERACTIONS
Drug-drug. Clotting factor concentrates (CFC) (activated prothrombin complex concentrate), bypassing agents (BPA) (anti-inhibitor coagulant complex): May cause an increased risk of thrombosis. Use cautiously together for breakthrough bleeding. Discontinue prophylaxis with CFC or BPA no later than 7 days after starting fitusiran.
Hormonal contraceptives: May increase risk of thrombotic events. Encourage non-hormonal contraceptive use prior to starting fitusiran and during therapy.
CONTRAINDICATIONS AND CAUTIONS
- Boxed Warning: Serious thrombotic events have occurred in patients treated with fitusiran with risk factors including persistent AT activity less than 15%, fitusiran 80 mg once monthly dosing, an indwelling venous catheter, and the post-operative setting when bleed management guidelines were not followed.
- Boxed Warning: Acute and recurrent gallbladder disease has occurred in patients treated with fitusiran, some requiring cholecystectomy or developing complications (pancreatitis). Consider alternative treatment for hemophilia if patient has a history of symptomatic gallbladder disease.
- Avoid use in patients with any level of liver impairment.
- Safety and effectiveness haven't been established in children younger than 12.
- Dialyzable drug: Unknown.
PREGNANCY-LACTATION-REPRODUCTION
- Studies during pregnancy are inadequate. Use only if potential benefit outweighs fetal risk.
- It's unknown if drug is present in human. Weigh benefit to patient against risk to infant before use.
Reactions in bold italics are
life-threatening.
Released: August 2025
Nursing Drug Handbook
© 2025 Wolters Kluwer
gepotidacin
Blujepa
Pharmaceutical company: GlaxoSmithKline
Pharmacologic classification: Triazacenaphthylenes
Therapeutic classification: Antibiotic
AVAILABLE FORMS
Tablets: 750 mg
INDICATIONS AND DOSAGES
Uncomplicated UTIs caused by Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii complex, Staphylococcus saprophyticus and Enterococcus faecalis
Female adults and children age 12 and older weighing at least 40 kg: 1500 mg PO twice daily approximately 12 hours apart for 5 days.
ADVERSE REACTIONS
CNS: headache, dizziness.
GI: abdominal pain, diarrhea, flatulence, nausea, soft feces, vomiting.
GU: vulvovaginal candidiasis.
INTERACTIONS
Drug-drug. Acetylcholinesterase inhibitors (aricept, donepezil): May increase the effect of inhibitors. Monitor for excessive cholinergic effects.
Anticholinergics (benztropine, oxybutynin): May decrease effects of anticholinergic agents. Monitor for therapeutic effect.
CYP3A4 Substrates with a narrow therapeutic index (quinidine, cyclosporine): May increase substrate level. Avoid use together.
Depolarizing neuromuscular blocking agents (succinylcholine): May increase effect of neuromuscular blocking agent. Monitor for exaggerated neuromuscular blockade.
Digoxin: May increase digoxin level. Monitor digoxin level.
Non-depolarizing neuromuscular blocking agents (rocuronium, pancuronium): May decrease effect of neuromuscular blocking agent. Monitor for effectiveness.
QT-prolonging agents (antiarrhythmics, haloperidol): May further increase risk of QTc prolongation. Avoid use together.
Strong CYP3A4 Inducers (phenobarbital, carbamazepine, phenytoin rifampin): May decrease level of gepotidacin. Avoid use together.
Strong CYP3A4 Inhibitors (clarithromycin, itraconazole, nelfinavir ritonavir): May increase level of gepotidacin. Avoid use together.
Drug-Herb. St. John's Wort: May decrease drug level. Discourage use together.
Drug-Food. Grapefruit juice: May increase gepotidacin level. Discourage use together.
CONTRAINDICATIONS AND CAUTIONS
- Contraindicated in patients with a severe hypersensitivity to gepotidacin.
- Drug may cause QTc prolongation. Avoid use in patients with a history of QTc interval prolongation, relevant pre-existing cardiac disease, or currently taking antiarrhythmic agents or other medications that may prolong the QTc interval.
- Use cautiously in patients with medical conditions that may be exacerbated by acetylcholinesterase inhibition (bradycardia, heart block, arrhythmias, hypotension, gastric ulcers).
- Drug may cause CDAD, ranging in severity from mild diarrhea to fatal colitis, which may occur more than 2 months after administration.
- Avoid use in patients with CrCl less than 30 mL/minute or Child-Pugh class C liver impairment.
- Safety and effectiveness haven't been established in children less than 12 years or weighing less than 40 kg.
- Dialyzable drug: Unknown.
PREGNANCY-LACTATION-REPRODUCTION
- Studies during pregnancy are inadequate to evaluate risk.
- Enrollment in a pregnancy exposure registry is encouraged (GlaxoSmithKline 1-888-825-5249).
- Based on animal study, drug is likely present in human milk. Weigh benefit to patient against risk to infant before use.
Reactions in bold italics are
life-threatening.
Released: August 2025
Nursing Drug Handbook
© 2025 Wolters Kluwer
isatuximab-irfc
Sarclisa
Pharmaceutical company: Sanofi-Aventis U.S. LLC
Pharmacologic classification: Monoclonal antibodies
Therapeutic classification: Antineoplastics
AVAILABLE FORMS
Injection: 100 mg/5 ml, 500 mg/25 ml single-dose vial
INDICATIONS AND DOSAGES
Adjust-a-dose (all indications): Interrupt isatuximab for grade 2 or 3 infusion-related reactions. If symptoms resolve or improve to grade 1, restart isatuximab infusion at half of the initial infusion rate. If after 30 minutes symptoms do not recur, the infusion rate may be increased to the initial rate, and then further increased incrementally as recommended. Permanently discontinue for grade 4 infusion-related reactions or anaphylactic reaction. For patients who need recovery of blood counts in the event of hematological toxicity, delay dose if needed. Dose reductions of isatuximab aren't recommended. Refer to manufacturer's instructions for doing information and toxicity-related dosage adjustments for drugs used in combination.
Multiple myeloma in combination with pomalidomide and dexamethasone in patients who have received at least 2 prior therapies including lenalidomide and a proteasome inhibitor
Adults: 10 mg/kg by IV infusion. Cycle 1 (28-day cycle), give weekly on days 1, 8, 15, 22; then cycle 2 and beyond give days 1, 15. Continue until disease progression or unacceptable toxicity. Premedicate with dexamethasone 40 mg PO or IV (or 20 mg PO or IV for patients age 75 years and older).
Relapsed or refractory multiple myeloma in combination with carfilzomib and dexamethasone in patients who have received 1 to 3 prior lines of therapy
Adults: 10 mg/kg by IV infusion. Cycle 1 (28-day cycle), give weekly on days 1, 8, 15, 22; then cycle 2 and beyond give days 1, 15 of every 28-day cycle. Continue until disease progression or unacceptable toxicity. Premedicate with dexamethasone 20 mg IV on infusion days, PO on day 22 in cycle 2 and beyond, and PO on day 23 in all cycles).
Newly diagnosed multiple myeloma in combination with bortezomib, lenalidomide, and dexamethasone in patients who aren't eligible for autologous stem cell transplant (ASCT)
Adults: 10 mg/kg by IV infusion. Cycle 1 (42-day cycle) give days 1, 8, 15, 22, 29; then cycles 2 to 4 give days 1, 15, 29. Cycles 5 to 17 (28-day cycles) give every 2 weeks on days 1, 15. Cycles 18 and beyond (28-day cycles) give every 4 weeks on day 1. Continue until disease progression or unacceptable toxicity. Premedicate with dexamethasone 20 mg (IV on the days of isatuximab infusions, PO on other days).
ADVERSE REACTIONS
CNS: fatigue, asthenia, peripheral sensory neuropathy, insomnia.
CV: HF, HTN, peripheral edema.
EENT: cataract.
GI: diarrhea, nausea, vomiting, constipation.
Hematologic: anemia, febrile neutropenia, lymphopenia, thrombocytopenia.
Musculoskeletal: back pain, pain.
Respiratory: URI, pneumonia, bronchitis, dyspnea, cough.
Other: infusion-related reactions, infections, second primary malignancies.
INTERACTIONS
None reported by the manufacturer.
CONTRAINDICATIONS AND CAUTIONS
- Contraindicated in those with severe hypersensitivity to isatuximab, or to any of its components.
- Alert: Drug may cause serious infusion-related reactions, including life-threatening anaphylactic reactions or cytokine release syndrome; and life-threatening infections.
- May increase the incidence of second primary malignancies during and after treatment.
- Older patients may have greater sensitivity to isatuximab, including neutropenia.
- Safety and effectiveness in children have not been established.
- Dialyzable drug: Unknown.
PREGNANCY-LACTATION-REPRODUCTION
- Drug can cause fetal harm. Fetal immune cell depletion and decreased bone density can occur.
- Patients of childbearing potential should use effective contraception during treatment and for 5 months after the last dose of isatuximab. The combination pomalidomide and lenalidomide are contraindicated during pregnancy because they may cause birth defects or death of the fetus.
- It's unknown if isatuximab is present in human milk. Because of the potential for serious adverse reactions in the breastfed child, breastfeeding isn't recommended during treatment.
Reactions in bold italics are
life-threatening.
Released: August 2025
Nursing Drug Handbook
© 2025 Wolters Kluwer