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Risdiplam

Generic name: evrysdi
drug class unclassified agents

What is Risdiplam?

Risdiplam treats a genetic disorder called spinal muscular atrophy, which is characterized by weakness and muscle wasting. Risdiplam can be used in adults and children older than 2 months. Risdiplam can be used in other ways not mentioned in this guide.

Side effects of Risdiplam

Identify any symptoms of an allergic reaction immediately: hives, difficulty breathing or swelling of face, lips or throat. Seek medical assistance as soon as possible if any such reactions arise.

Risdiplam can cause serious side effects. If you experience:

  • You may experience pain or burning after urinating.
  • Signs of lung infections: fever, cough with mucus production and chest discomfort as well as shortness of breath are symptoms.

Risdiplam can cause the following side effects:

  • Fever, lung infection;
  • nausea, vomiting;
  • diarrhea, constipation;
  • is rash
  • Cold symptoms, like congestion and sneezing.

There may be other side effects. Need medical advice about side effects? Speak with your physician. The fda can be contacted at 1-800-fda-1088 to report side effects.

Similar/related drugs

Evrysdi, spinraza, zolgensma, nusinersen, and onasemnogene abeparvovec

Warnings

Please read all the instructions on the label or package of your medication. Inform your healthcare provider about your medical conditions, your allergies, and the medicines you are using.

Before you take this drug

Risdiplam should not be used in children younger than two months of age. If you've ever had liver issues, tell your doctor. Before starting this treatment, you may need a negative pregnancy result. Inform your doctor of any plans to get pregnant. Risdiplam can harm an unborn child. Use effective contraception during your treatment with risdiplam and for a minimum of 1 month following the last dose. If you become pregnant, inform your physician as soon as possible. Risdiplam can affect men's fertility. Speak to your doctor about any concerns you may have.

How to take Risdiplam?

Read all instructions or guides that come with your medication and follow all directions. Follow the directions on the label. You will be taught by your healthcare provider how to prepare the daily dose. Follow all directions included with your medication for use. Risdiplam comes as a liquid, which must be mixed in the pharmacy. This medicine should not be taken in powder form. Risdiplam should be measured carefully. Only use one of the provided dosing syringes (choose a syringe that is the correct size). Use only the provided syringes to measure your medicine. Do not use any other measuring device, such as a spoon. Only prepare a dose when you're ready to administer it. You must administer the medicine in 5 minutes after placing the risdiplam in the oral syringe. If the medicine is not taken within 5 minutes, you should throw it out and prepare another dose.

Take this medication at the same time every day, after eating. After feeding, administer the medicine to the child who is using risdiplam. Risdiplam should not be mixed with milk or infant formula. Drink a glass of water after you take the medicine to ensure that you have swallowed the full dose. Do not take another dose if the entire dose was not swallowed or if vomiting occurs shortly after taking risdiplam. Do not take another dose until the next scheduled time. Your doctor will first inspect the tube if you plan to administer this medication through a gastrostomy or nasogastric tube. Follow the instructions on how to administer risdiplam via the tube. After each dose, flush the tube out with water. Do not get this medication in your eyes or on your face. If you do, wash the area with soap and warm water. The oral syringe can be reused. After each use, wash the syringe and let it air-dry. Call your pharmacist if your syringe has been damaged or lost. Store risdiplam upright in its original bottle. Do not expose the bottle to light or freeze it. Close tightly when not in use. If it's been more than 64 days since the liquid was mixed in the pharmacy, throw away any liquid that has not been used. The dose of risdiplam is based on the weight of the child. As your child grows, the dose requirements will change. Do not change the dose or stop taking risdiplam without consulting your doctor.

Details on dosage

Adult dose for spinal muscular atrophy:

5 mg taken orally, once per day
comments:
see other comments/administration advice for important information on dose preparation and administration.
Use: to treat spinal muscular atrophy.

The usual pediatric dose for spinal muscular atrophy (sma) is:

0.2 mg/kg once daily, orally, for 2 months to 2 years.
Weight less than 20 kg for 2-year-olds: 0.25 mg/kg once daily.
Weight 20 kg and above: 5 mg once daily.
Comments:
see other comments/administration advice for important information on dose preparation and administration.
Use: to treat spinal muscular atrophy among patients older than 2 months.

What happens if i miss the dose?

If you miss a dose, take it as soon as possible. However, if the dose is more than six hours late, skip that dose. The next day, go back to your regular schedule. Use only one dose at a time.

What happens if i overdose?

Call 1-800-222-1222 for poison help or seek immediate medical attention.

What should be avoided?

If your doctor prescribes any restrictions regarding food, beverage, or activity, follow their instructions.

Interaction with other drug

Other drugs, such as vitamins and herbal remedies, may also affect risdiplam. Inform your doctor of all the medicines you are taking and those that you stop or start using.

DRUG STATUS

Availability

Prescription only

Pregnancy & Lactation

CSA Schedule*
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