leniolisib
Joenja
Pharmaceutical company: Pharming Healthcare
Pharmacologic classification:Kinase inhibitor
Therapeutic classification:Immunomodulator
AVAILABLE FORMS
Capsules: 70 mg
INDICATIONS AND DOSAGES
Activated phosphoinositide 3-kinase delta syndrome
Adults and children age 12 and older weighing at least 45 kg: 70 mg PO b.i.d. 12 hours apart.
CONTRAINDICATIONS AND CAUTIONS
- Use in patients with Child-Pugh class B and C liver impairment hasn't been established and isn't recommended.
- Safety and effectiveness in children younger than age 12 or weighing less than 45 kg has not been established.
- Dialyzable drug: Unlikely.
PREGNANCY-LACTATION-REPRODUCTION
- This drug may cause fetal harm.
- Patients of childbearing potential should use effective contraception during therapy and for 1 week after the last dose.
- There is no information on the presence of this drug in human milk. Due to the potential for adverse reactions in the infant, breastfeeding during treatment and for 1 week after the last dose isn't recommended.
INTERACTIONS
Drug-drug.
BCRP, OATP1B1, OATPB13 substrates (methotrexate, rosuvastatin, pravastatin, prazosin)May increase level of substrate. Avoid use together.
CYP1A2 substrates with a narrow therapeutic index (theophylline): May increase levels.
Avoid use together.
Live vaccines: Leniolisib may decrease vaccine effectiveness. Avoid use together.
Moderate and strong CYP3A4 inducers (phenytoin, rifampin, efavirenz): May decrease leniolisib level. Avoid use together.
Strong CYP3A4 inhibitors (clarithromycin, itraconazole, ketoconazole, ritonavir): May increase leniolisib level. Avoid use together.
Drug-herb. St. John's wort: May decrease leniolisib level. Avoid use together.
Drug-food. Grapefruit juice: May increase leniolisib level. Avoid use together.
ADVERSE REACTIONS
CNS: headache, fatigue, fever.
CV: tachycardia.
EENT: sinusitis.
GI: diarrhea.
Hematologic: neutropenia.
Musculoskeletal: neck pain, back pain.
Skin: atopic dermatitis, alopecia.
Reactions in bold italics are life-threatening.
Released: July 2023
Nursing Drug Handbook
© 2023 Wolters Kluwer
trofinetide
Daybue
Pharmaceutical company: Acadia Pharmaceuticals
Pharmacologic classification: Glycine-proline-glutamate analog
Therapeutic classification: Miscellaneous CNS agent
AVAILABLE FORMS
Oral solution: 200 mg/mL
INDICATIONS AND DOSAGES
Rett syndrome
Adults and children age 2 and older weighing 50 kg or more: 12,000 mg (60 mL) PO b.i.d.
Adults and children age 2 and older weighing 35 kg to less than 50 kg: 10,000 mg (50 mL) PO b.i.d.
Adults and children age 2 and older weighing 20 kg to less than 35 kg: 8,000 mg (40 mL) PO b.i.d.
Adults and children age 2 and older weighing 12 kg to less than 20 kg: 6,000 mg (30 mL) PO.
Adults and children age 2 and older weighing 9 kg to less than 12 kg: 5,000 mg (25 mL) PO.
Adjust-a-dose: Interrupt, reduce dose, or discontinue trofinetide for severe diarrhea, suspected dehydration, or significant weight loss.
CONTRAINDICATIONS AND CAUTIONS
- Use in patients with moderate or severely reduced GFR is not recommended.
- Safety and effectiveness in children less than 2 years have not been established.
- Dialyzable drug: Unlikely.
PREGNANCY-LACTATION-REPRODUCTION
- There are no adequate studies in women who are pregnant. Use during pregnancy only if benefit outweighs risk to the fetus.
- It isn't known if this drug appears in human milk. Use cautiously during breastfeeding.
INTERACTIONS
Drug-drug. A CYP3A4 substrates (carbamazepine, midazolam): May increase level of substrate. Monitor sensitive substrates with a narrow therapeutic index.
OATP1B1, OATP1B3 substrates (valproic acid, methotrexate): May increase level of substrate. Avoid concomitant use with substrates with a narrow therapeutic index.
ADVERSE REACTIONS
CNS: fever, seizures, anxiety, fatigue.
EENT: nasopharyngitis.
GI: diarrhea, vomiting, decreased appetite.
Metabolic: weight loss.
Reactions in bold italics are life-threatening.
Released: July 2023
Nursing Drug Handbook
© 2023 Wolters Kluwer
zavegepant
Zavzpret
Pharmaceutical company: Pfizer, Inc.
Pharmacologic classification: Calcitonin gene-related peptide receptor antagonist
Therapeutic classification: Antimigraine drug
AVAILABLE FORMS
Nasal spray: 10 mg per unit-dose device
INDICATIONS AND DOSAGES
Acute treatment of migraine with or without aura
Adults: 10 mg as a single spray in one nostril, as needed. The maximum dosage is 10 mg in 24 hours.
CONTRAINDICATIONS AND CAUTIONS
- Contraindicated in patients with a history of hypersensitivity to the drug or any of its components.
- Hypersensitivity reactions, including facial swelling and urticaria, have occurred.
- Avoid use in patients with creatinine clearance of less than 30 mL/minute and Child-Pugh class C liver impairment.
- Safety and effectiveness in children haven't been established.
- Dialyzable drug: Unknown.
PREGNANCY-LACTATION-REPRODUCTION
- There are no data on use during pregnancy. Pregnant patients with migraine may be at increased risk of preeclampsia and gestational hypertension.
- It isn't known if this drug appears in human milk. Use cautiously during breastfeeding.
INTERACTIONS
Drug-drug. Intranasal decongestants (azelastine, oxymetazoline): May decrease absorption of zavegepant. Avoid use together. If concomitant use is unavoidable, administer decongestants at least 1 hour after zavegepant.
OATP1B3 inducers (clotrimazole, progesterone), sodium taurocholate cotransporting polypeptide (NTCP) inducers: May decrease zavegepant level. Avoid use together.
OATP1B3 inhibitors (rifampin, clarithromycin), NTCP inhibitors (rifampin): May increase zavegepant level. Avoid use together.
ADVERSE REACTIONS
CNS: taste disorder.
EENT: nasal discomfort.
GI: nausea, vomiting.
Reactions in bold italics are life-threatening.
Released: July 2023
Nursing Drug Handbook
© 2023 Wolters Kluwer