What Is Pegvaliase?
Pegvaliase can be used to reduce the blood levels of phenylalanine in adult patients suffering from the condition phenylketonuria (PKU) that is not controlled by other treatments.Pegvaliase is only available through a licensed pharmacy as part of the specific program.Pegvaliase can also be used for reasons not mentioned in this medication guide.
Side effects of Pegvaliase
Stop taking Pegvaliase and seek emergency medical assistance in the event that you exhibit indications or warnings.
- Hives, rash, itching;
- Nausea, vomiting, diarrhea;
- The loss of bladder control;
- Fast heartbeats;
- Wheezing and chest tightness; difficulty breathing;
- Flushing (warmth, redness, or tingly sensation) (also known as
- Swelling of your lips, face, and tongue.
Common negative side effects of pegvaliase include:
- Cough and stuffy nose;
- Pain in the throat and mouth;
- Dizziness;
- Anxiety;
- Low levels of phenylalanine in the blood;
- A skin reaction that spreads (itching, redness, or rash) and can last for at least 14 days;
- Pain, joint pain;
- Nausea, vomiting, stomach pain, diarrhea;
- Tiredness;
- Swelling, tenderness, or pain in the area of redness, itching, or swelling in the area where the injection was made.
It isn't a complete listing of all possible adverse impacts, as other things may occur. Consult your physician for medical advice regarding the effect. It is possible to report any adverse reaction to FDA by calling 1-800-FDA-1088.
Warnings
Pegvaliase could cause a severe allergic reaction. The first dose is administered in a medical setting.See a doctor immediately in the event that you exhibit symptoms that are warning signs of an allergic reaction, like hives, itching, or wheezing. difficulty breathing; swelling of your throat or face. Your doctor might recommend you carry an epinephrine injection kit with you at all times.
Before you take this drug
Pegvaliase could trigger an allergic reaction. The doctor might prescribe an injection kit containing epinephrine to take in case of an extremely allergic reaction. Make sure to carry this kit in your bag throughout the day.Consult your physician if you believe you may not be able to give yourself an urgent injection of epinephrine.
Follow the instructions of your doctor on using pegvaliase when you are expecting. Controlling your phenylalanine levels is crucial during pregnancy. Your name might be on a pregnancy registry to monitor your effects on the baby.Check with your doctor for advice on whether it is safe to breastfeed while taking this medicine.The use of this product is not allowed to those who are not 18 years old or older.
How to take Pegvaliase?
Follow the directions on your prescription label and go through all medication guides or instruction sheets. Your doctor may alter your dosage. Make sure you take the medication exactly as prescribed.
Pegvaliase is injected beneath the skin. It is possible to receive other medicines to help you avoid adverse side effects or even reactions to allergies.Your first dose in a medical setting to ensure you don't have the reaction of an allergyTake note of all the instructions for use. Consult your physician or pharmacist for assistance.Inject it at the time you're prepared to administer it. Contact your pharmacist if the medicine appears cloudy, has changed color, or has particles.
Don't shake the prefilled syringe, or you could ruin the medicine.Your healthcare professional will inform you of the best place to inject your pegvaliase. Do not inject the same spot twice in one row.It is possible that you will need someone present for a minimum of 1 hour after injecting the medicine at home to look out for any signs that indicate an allergic reaction. They will administer the injection of epinephrine as required.
Check out the warning card about allergies and discover the signs to be looking for. Keep the card in your pocket throughout the day.You'll require regular medical tests.You'll need to adhere to the specific diet. Follow all the instructions given by your dietitian or doctor. Find out about the foods you should avoid or eat.Place it in the refrigerator, but do not freeze it.
It is possible to store the medicine for 30 days at room temperature inside the original container, shielded from sunlight. Do not place the medicine back in the fridge. Get rid of any medicine you haven't used after 30 days or if it has expired. The deadline for expiration on the prescription label has been reached.
Toss out a syringe filled with prefilled medicine after one use, even if there's some medicine in it.Don't reuse needles or syringes. Put them in an impervious to puncture "sharps" container and dispose of it in accordance with local or state laws. Be sure to keep it out of range of children and pets.
Details on dosage
Usual Adult Dose for Phenylketonuria:
Indication: 2.5 mg subcutaneously once each week for 4 weeks.
Titrate in a gradual manner as tolerated over five weeks at the minimum (described below). Additional time could be needed in advance of each increase in accordance with the tolerability.
RECOMMENDED TITRATION SCHEDULE:
Day 1: 2.5 mg subcutaneously twice every week
Week 2: Subcutaneously, 10 mg every week
Week 3 Subcutaneously administer 10 mg once each week.
Week 4: Subcutaneously, 10 mg four times per week
Week 5: Subcutaneously, 10 mg once per day
Week 6: Subcutaneously, 20 mg once every day
After at least 24 months of 20 mg/day dosage, look at increasing dosage to 40 mg/day in patients who are not able to obtain blood phenylalanine levels that are controlled.
After at least 16 weeks, at a dose of 40 mg/day, it is possible to consider increasing dosage up to 60 mg/day for those not able to achieve the goal of controlling blood phenylalanine.
Maintenance dose 20–60 mg subcutaneously, once per day; the maintenance dose must be customized to achieve blood phenylalanine levels that are controlled (blood phenylalanine levels less than or equivalent to 600 micromol/L).
MAXIMUM DOSE:
If, after 16 weeks of 60 mg/day, the patient has not had a satisfactory response to therapy, it should be stopped.
Comments:
Start the dose under the direction of a health professional. Treatment should be administered by a medical professional experienced in managing PKU.
Get a baseline blood phenylalanine level. Check the tolerability of the treatment, blood phenylalanine levels, and dietary protein and phenylalanine consumption throughout the treatment.
• A therapeutic response might not be realized until the titration process to a safe dosage for maintenance is reached; determine doses individually and use the dose that is most effective and well tolerated.
Use: To lower blood phenylalanine levels for patients suffering from phenylketonuria (PKU) who suffer from uncontrolled blood phenylalanine levels of more than 600 micromol/L with current treatment.
What happens If I miss a dose?
Do not miss the missed dose, and take your next dose at the normal time. Don't take two doses at the same time.
What happens if I overdose?
For medical emergencies, seek emergency medical attention or contact the Poison Help line toll-free at 1-800-222-1222.
What should be avoided?
Avoid injecting into skin that's damaged, red, hard and tender, damaged, or irritated. Avoid injecting pegvaliase into skin areas that have birthmarks, scars, moles, or tattoos.
Interaction with other drugs
Other medications can influence pegvaliase, such as prescription and over-the-counter medicines, vitamins, and herbal products. Inform your physician about any other medications you are taking.
