viltolarsen

Absorption: IV administration results in complete bioavailability.

Distribution: Extensively distributed to extravascular tissues.

Metabolism/Excretion: Not hepatically metabolized. Primarily excreted as unchanged drug in the urine.

Half-Life: 2.5 hr.

Time/Action Profile ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
IV	unknown	1 hr (end of infusion)	unknown

Contraind./Precautions ⬆ ⬇

Contraindicated in:

None.

Use Cautiously in:

Renal impairment;
OB: Safety not established in pregnancy;
Lactation: Safety not established in breastfeeding.

Adv. Reactions/Side Effects ⬆ ⬇

CV: ↓ejection fraction

Derm: urticaria

GI: abdominal pain, diarrhea, vomiting

GU: renal impairment

Local: injection site reaction

MS: arthralgia

Neuro: confusion

Resp: cough, upper respiratory tract infection

Misc: fever

Interactions ⬆ ⬇

Drug-drug:

None reported.

Route/Dosage ⬆ ⬇

IV (Adults and Children ): 80 mg/kg once weekly.

Availability ⬆ ⬇

Solution for injection: 50 mg/mL

Assessment ⬆ ⬇

Evaluate baseline motor skills, ambulation, muscle strength, and frequency of falls. Observe for symptomatic response, motor function ↓, and progressive muscle weakness, including respiratory (dyspnea, respiratory infections, dysphagia) and cardiac (fatigue, peripheral edema).
Monitor for signs and symptoms of nephrotoxicity during treatment (nausea, vomiting, pruritus, polyuria, oliguria, hematuria, foamy urine, flank or abdominal pain).
Monitor for signs and symptoms of hypersensitivity reactions (rash, urticaria, pruritis, flushing, dizziness, vomiting, abdominal pain) and angioedema (swelling of throat, lips, tongue, or face; dyspnea; wheezing; hoarseness). Discontinue immediately and provide supportive care.

Lab Test Considerations:

Measure serum cystatin C and urine protein-to-creatinine ratio prior to initiation and every 3 mo. Measure urine dipstick prior to initiation and monthly. Serum creatinine may not be a reliable measure of kidney function in patients with Duchenne muscular dystrophy; use of these alternative monitoring parameters recommended.
- Obtain urine samples prior to infusion or at least 48 hr after the most recent infusion; only use urine expected to be free of excreted viltolarsen for monitoring of urine protein.
- Monitor kidney function during therapy; especially in patients with known renal impairment. Consider eGFR measurement prior to initiation.

Implementation ⬆ ⬇

IV Administration:

Allow vials to warm to room temperature. Mix the contents of each vial by gently inverting 2–3 times. Do not shake. Do not use if the solution in the vials is discolored or contains particulate matter.
Y-Site Incompatibility:
- Do not administer other drugs through same IV line.

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of viltolarsen. Advise patient to read Patient Information before starting therapy.
Explain need for continued medical follow-up to assess effectiveness and possible side effects of medication. Periodic lab tests may be needed.
Advise patient to immediately report signs or symptoms of kidney toxicity (nausea; vomiting; itchiness; urinating more or less than usual; foamy, bubbly, or bloody urine; swelling in the feet and ankles).
Advise patient to notify health care professional if signs and symptoms of infusion reactions (fever, chills or shivering, nausea, vomiting, diarrhea, tiredness, dizziness, sweating, hives, itching, shortness of breath, wheezing) occur.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking other medications.
Rep: Advise women of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇

Pharmacokinetics ⬆ ⬇