Description
Patisiran injection is used to treat polyneuropathy (nerve disease) caused by hereditary transthyretin-mediated amyloidosis.
This medicine is to be given only by or under the direct supervision of your doctor.
This product is available in the following dosage forms:
- Solution
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of patisiran injection in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of patisiran injection in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Vitamin A deficiency—Use with caution. May make this condition worse.
Proper Use
A doctor or other trained health professional will give you this medicine. It is given through a needle that is placed into one of your veins.
You may also receive other medicines (including allergy medicine, fever medicine, steroids) at least 60 minutes before starting treatment to help prevent possible unwanted effects during the injection. You may also be given vitamin A supplements as needed.
Precautions
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.
This medicine may cause infusion-related reactions, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you start to have a fever, chills or shaking, dizziness, trouble breathing, itching or rash, lightheadedness or fainting after receiving this medicine.
This medicine may lower the vitamin A levels in your body, which may cause eye or vision problems (eg, night blindness, blurred vision, difficulty with reading, or any other change in vision). Your doctor may want your eyes be checked by an ophthalmologist (eye doctor).
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
More common
- Back pain
- body aches or pain
- chest tightness
- chills
- cough
- difficulty in breathing
- ear congestion
- feeling of warmth
- fever
- headache
- loss of voice
- nasal congestion
- nausea
- redness of the face, neck, arms, and occasionally, upper chest
- runny nose
- sneezing
- sore throat
- unusual tiredness or weakness
- vomiting
Less common
- Blurred vision
- chest pain
- cough producing mucus
- dizziness
- dry eye
- fainting
- pounding, slow heartbeat
- seeing floating dark spots or material before the eyes
Rare
- Blistering, crusting, irritation, itching, or reddening of the skin burning, pain, redness, or swelling at the injection site
- changes in skin color, pain, tenderness, or swelling of the foot or leg
- cracked, dry, scaly skin
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Less common
- Belching
- feeling of constant movement of self or surroundings
- heartburn
- indigestion
- muscle spasms
- sensation of spinning
- stomach discomfort, upset, or pain
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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