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AVAILABLE FORMS

Injection: 0.6 mg/0.6 mL single-dose autoinjector; 0.6 mg/0.6 mL single-dose prefilled syringe

INDICATIONS AND DOSAGES

Treatment of severe hypoglycemia in patients with diabetes

Adults and children age 6 and older: 0.6-mg subcut injection. If no response after 15 minutes, may repeat with an additional 0.6 mg subcut.

CONTRAINDICATIONS AND CAUTIONS

• Contraindicated in patients with pheochromocytoma. If a patient develops a substantial increase in blood pressure and a previously undiagnosed pheochromocytoma is suspected, consider giving 5 to 10 mg of phentolamine mesylate IV.
• Contraindicated in patients with insulinoma. This drug may stimulate exaggerated insulin release from an insulinoma and cause hypoglycemia. If a patient develops symptoms of hypoglycemia after a dose of dasiglucagon, give PO or IV glucose.
• Allergic reactions have been reported with glucagon products.
• This drug is effective in treating hypoglycemia only if sufficient hepatic glycogen stores are present. Patients in a starvation state, with adrenal insufficiency or chronic hypoglycemia may not have adequate levels of hepatic glycogen for the drug to be effective. Treat these patients with glucose.
• The safety and effectiveness of this drug have not been established in patients younger than age 6.
• Dialyzable drug: Unknown.

PREGNANCY-LACTATION-REPRODUCTION

• There are no available data on dasiglucagon use in pregnant females. However, untreated hypoglycemia in pregnancy can cause complications and may be fatal.
• There is no information on the presence of this drug in human milk, its effects on the breastfed infant, or milk production. Dasiglucagon would be expected to be broken down to amino acids in the infant's digestive tract and is therefore unlikely to cause harm to an exposed infant.

INTERACTIONS

Drug-drug. Beta-blockers: May transiently increase pulse and blood pressure. Monitor patient’s vital signs.

Indomethacin: May decrease antihypoglycemic effect of dasiglucagon or may produce hypoglycemia. Use together cautiously.

Warfarin: May increase anticoagulant effect of warfarin. Monitor patient closely.

ADVERSE REACTIONS

CNS: headache.

CV: hypertension, hypotension, bradycardia, presyncope, palpitations, orthostatic intolerance.

GI: nausea, vomiting, diarrhea.

Skin: injection site pain.

Other: hypersensitivity reactions.

Reactions in bold italics are life-threatening.

Released: June 2021

© 2021 Wolters Kluwer

AVAILABLE FORMS

Injection: 20-mg single-dose vial

INDICATIONS AND DOSAGES

Relapsed or refractory multiple myeloma, in combination with dexamethasone, in those who received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody

Adults: 40-mg IV infusion over 30 minutes on day 1 of each 28-day cycle in combination with dexamethasone 40 mg PO or IV on days 1, 8, 15 and 22 of each cycle until disease progression or until unacceptable toxicity.

Adjust-a-dose: For patients age 75 or older, reduce dose of dexamethasone to 20 mg. Refer to the manufacturer’s instruction for toxicity-related dosage adjustments.

CONTRAINDICATIONS AND CAUTIONS

• Contraindicated in patients hypersensitive to melphalan flufenamide or melphalan.
• Dosages exceeding the recommended dose for relapsed and refractory multiple myeloma are associated with mortality.
• This drug may increase the risk of secondary malignancies, such as myelodysplastic syndromes or acute leukemia. Monitor patients long-term for secondary malignancies.
• This drug is not indicated or recommended for use as a conditioning regimen for transplant outside of controlled clinical trials.
• This drug has not been studied in patients with creatinine clearance 15 to 44 mL/min.
• Safety and effectiveness in children have not been established.
• Dialyzable drug: Unknown.

PREGNANCY-LACTATION-REPRODUCTION

• This drug can cause fetal harm. Advise pregnant women of the risk to a fetus.
• Advise females of reproductive potential to use effective contraception during treatment and for 6 months after the last dose.
• Verify pregnancy status in females of reproductive potential prior to initiating this drug.
• Advise males with female partners of reproductive potential to use effective contraception during treatment and for 3 months after the last dose.
• There is potential for serious adverse reactions in a breastfed child; advise women not to breastfeed during treatment and for 1 week after the last dose.
• This drug can cause amenorrhea and result in infertility.
• This drug may impair male fertility and irreversible testicular suppression.

INTERACTIONS

None reported.

ADVERSE REACTIONS

CNS: pyrexia, fatigue, asthenia, headache, dizziness, insomnia.

CV: peripheral edema, hemorrhage.

GI: nausea, diarrhea, constipation, vomiting, decreased appetite.

Hematologic: thrombocytopenia, neutropenia, febrile neutropenia, leukopenia, hemorrhages, anemia.

Metabolic: hypokalemia, hypocalcemia.

Musculoskeletal: bone pain, back pain, arthralgia, extremity pain.

Respiratory: pneumonia, respiratory tract infection, respiratory failure, cough, dyspnea, exertional dyspnea.

Other: sepsis, general physical health deterioration, hypersensitivity reaction.

Reactions in bold italics are life-threatening.

Released: June 2021

© 2021 Wolters Kluwer

AVAILABLE FORMS

Tablets: 2 mg, 3 mg, 4 mg, 5 mg, 6 mg, 7 mg, 8 mg, 9 mg, 10 mg, and 20 mg

INDICATIONS AND DOSAGES

Relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease

Adults: Initially, one tablet PO daily from starter pack for days 1 to 14: days 1 and 2, 2 mg; days 3 and 4, 3 mg; days 5 and 6, 4 mg; day 7, 5 mg; day 8, 6 mg; day 9, 7 mg; day 10, 8 mg; day 11, 9 mg; days 12 to 14, 10 mg;then begin maintenance dose of 20 mg PO once daily starting on day 15.

CONTRAINDICATIONS AND CAUTIONS

• Contraindicated in those with a history of MI, unstable angina, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization, or class III or IV heart failure within the last 6 months.
• Contraindicated in those with Mobitz type II second-degree, third-degree atrioventricular (AV) block, or sick sinus syndrome, or sino-atrial block, unless patient has a functioning pacemaker.
• Use in those with moderate or severe hepatic impairment (Child-Pugh class B and C) is not recommended.
• Use cautiously in patients with preexisting heart and cerebrovascular conditions, hypertension, arrhythmias, prolonged QTc interval, risk for prolonged QTc interval; or concurrent drug therapy that slows the heart rate or AV conduction, or prolongs the QTc interval after consultation with a cardiologist on a monitoring strategy.
• Use cautiously in those with severe respiratory disease (pulmonary fibrosis, asthma, chronic obstructive pulmonary disease). Dose-dependent reductions in respiratory function were seen in patients treated with this drug.
• Use cautiously in patients with a history of uveitis or diabetes; this drug may increase the risk of macular edema. Regular follow-up examinations of the fundus should be obtained in these patients. 
• This drug may increase the risk of infections, including life-threatening and rare fatal infections.
• This drug may cause severe exacerbation of MS, including disease rebound, after discontinuation. Monitor patient closely and treat as clinically indicated.
• Safety and effectiveness in children have not been established.
• Use cautiously in elderly patients because of the potential for decreased hepatic, renal, or cardiac function, concomitant disease, or other drug therapy.
• Dialyzable drug: No.
• Overdose S&S: bradycardia, AV conduction block.

PREGNANCY-LACTATION-REPRODUCTION

• This drug may cause fetal harm. Advise women of childbearing potential of the risk prior to the start of treatment.
• Women of childbearing potential should use effective contraception during and for 1 week after the end of therapy.
• There are no data on the safety of breastfeeding, effects on the breastfed infant or the production of human milk. Consider benefits of breastfeeding, clinical need of the drug to the mother, and potential adverse effects on the infant.

INTERACTIONS

Drug-drug. Alemtuzumab: Alemtuzumab effects are prolonged and may have additive immune suppressive effects. Initiating treatment with ponesimod after alemtuzumab is not recommended.

Antineoplastic, immunosuppressive, or immune-modulating therapies: Use together cautiously due to additive immunosuppressive effects. When switching from drugs with prolonged immune effects, consider half-life and mode of action of these drugs.

Beta-blockers (atenolol, metoprolol, carvedilol, labetalol): May have additive heart rate lowering effects. Use cautiously together; dose interruption of beta-blocker may be necessary. Beta-blocker can be initiated in those receiving stable doses of ponesimod.

Beta interferon or glatiramer acetate: May have additive immunosuppressive effects, but ponesimod can generally be started immediately after discontinuation of these drugs.

Alert: Drugs that prolong QT interval (class Ia [quinidine, procainamide] and class III [amiodarone, sotalol] antiarrhythmics, verapamil, diltiazem, or other drugs that may decrease heart rate [digoxin]):May have additive effects on heart rate. Consult cardiologist prior to use together.

Drugs that slow heart rate or AV conduction:May have additive effects.Monitor patient closely and consult a cardiologist as appropriate.

Live-attenuated vaccine immunizations: May increase risk of infection. Administer live-attenuated vaccine at least 1 month prior to initiation of ponesimod and avoid during and from 1 to 2 weeks after treatment with ponesimod.

Strong CYP3A4 and UGT1A1 inducers (rifampin, phenytoin, carbamazepine): May decrease ponesimod levels. Use together is not recommended.

Vaccines: Drug may decrease effectiveness of vaccine during treatment and for up to 1 to 2 weeks after discontinuations. Avoid giving vaccines until 2 weeks after end of treatment.

Drug-lifestyle. Sun exposure: May cause an increase in cutaneous malignancies. Limit exposure to sunlight and ultraviolet light.

ADVERSE REACTIONS

CNS: dizziness, somnolence, pyrexia, vertigo, fatigue, migraine, insomnia, depression, seizures.

CV: bradycardia,AV conduction delay, hypertension, chest discomfort, peripheral edema.

EENT: rhinitis, dry mouth, sinusitis, macular edema.

GI: dyspepsia.

GU: UTI.

Hepatic: increased liver function tests.

Metabolic: hypercholesterolemia.

Musculoskeletal: joint swelling, back pain.

Respiratory: upper respiratory infection,dyspnea, cough, pneumonia.

Other: extremity pain, increased C-reactive protein, infections.

Reactions in bold italics are life-threatening.

Released: June 2021

© 2021 Wolters Kluwer