Evrysdi
Generic Name
Risdiplam
Manufacturer
Genentech/Roche
Country
Switzerland
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| evrysdi 075 mg oral solution | ৳ 401,407.00 | N/A |
Description
Overview of the medicine
Evrysdi (risdiplam) is an oral solution indicated for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients.
Uses & Indications
Dosage
Adults
The recommended daily dose is based on body weight, generally 0.25 mg/kg for patients up to 20 kg, and a maximum of 5 mg for patients over 20 kg. Administer orally once daily with food.
Elderly
No specific dose adjustment is required for elderly patients.
Renal_impairment
No dose adjustment is recommended for patients with mild to moderate renal impairment. Severe renal impairment has not been studied, so caution is advised.
How to Take
Evrysdi is for oral use only. Administer once daily, immediately after a meal, at approximately the same time each day. It must be prepared by a healthcare professional and administered by an oral syringe.
Mechanism of Action
Risdiplam is a survival motor neuron 2 (SMN2) splicing modifier that increases and sustains functional SMN protein levels. It works by modulating the splicing of SMN2 messenger RNA (mRNA) to increase the production of functional full-length SMN protein.
Pharmacokinetics
Onset
Clinical benefits are typically observed within months of initiation of treatment.
Excretion
Excretion is primarily fecal (53% of dose), with a smaller portion excreted renally (14% of dose).
Half life
The elimination half-life is approximately 50-60 hours in adults and children (≥2 years) and 30-40 hours in infants (2 months to <2 years).
Absorption
Rapidly absorbed after oral administration. Peak plasma concentrations (Tmax) are reached within 1 to 4 hours. Oral bioavailability is high.
Metabolism
Primarily metabolized by flavin-containing monooxygenase (FMO) 1 and 3, and to a lesser extent by cytochrome P450 (CYP) 3A4/5.
Side Effects
Contraindications
- •Hypersensitivity to the active substance (risdiplam) or to any of the excipients.
Drug Interactions
CYP3A inducers/inhibitors
Co-administration with strong CYP3A inducers or inhibitors is not expected to significantly alter risdiplam exposure, but caution is advised.
Substrates of MATE1, OCT1, OCT2, OATP1B1/B3
Risdiplam may increase plasma concentrations of these substrates. Exercise caution with co-administration.
Storage
Unreconstituted powder: Store at room temperature (below 30°C). Reconstituted solution: Store in a refrigerator (2°C to 8°C). Do not freeze. Keep the bottle upright and tightly closed.
Overdose
There is no specific antidote for Evrysdi overdose. In case of an overdose, symptomatic and supportive treatment should be initiated. Monitor vital signs and observe the patient's clinical status.
Pregnancy & Lactation
Based on animal studies, Evrysdi may cause fetal harm. Females of reproductive potential should be advised to use effective contraception during treatment and for at least 1 month after the last dose. It is unknown whether risdiplam is excreted in human milk. Breastfeeding is not recommended during treatment and for at least 1 month after the last dose.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Unreconstituted powder: Refer to the expiry date on the packaging. Reconstituted solution: Stable for 64 days when stored in a refrigerator (2°C to 8°C).
Availability
Global (USA, Europe, etc.)
Approval Status
FDA Approved
Patent Status
Patented
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