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Important Safety Information

JAVYGTOR Tablets for Oral Use and JAVYGTOR Powder for Oral Solution

What Important Information Should I Know About JAVYGTOR Tablets for Oral Use and Powder for Oral Solution?

Sapropterin Dihydrochloride can cause serious side effects including:

Severe allergic reactions, including anaphylaxis – JAVYGTOR is not recommended in patients with a history of anaphylaxis to Sapropterin Dihydrochloride. Stop taking JAVYGTOR and get medical help right away if you develop any of these symptoms of severe allergic reaction:

Wheezing or trouble breathing
Coughing
Flushing
Nausea
Feeling lightheaded or you faint
Rash

Inflammation of the lining of the stomach (gastritis) or esophagus (esophagitis) – Gastritis or esophagitis can happen with Sapropterin Dihydrochloride and may be severe. Patients should be monitored by their doctor for signs and symptoms of upper gastrointestinal mucosal inflammation. Call your doctor right away if you have any of these signs or symptoms:

Severe upper stomach area (abdominal) discomfort or pain, nausea and vomiting
Blood in your vomit or stool
Black, tarry stool
Difficulty swallowing
Loss of appetite
Pain in the throat

Phenylalanine (Phe) levels that are too low – Some PKU patients have experienced low blood Phe during treatment. Some children under the age of 7 years who take high doses of Sapropterin Dihydrochloride each day may experience low Phe levels

Too much or constant activity (hyperactivity) can happen with Sapropterin Dihydrochloride – Tell your doctor if you have any signs of hyperactivity, including:

Fidgeting or moving around too much
Talking too much
It is not possible to know if Sapropterin Dihydrochloride will work for you until you start treatment. Your doctor will check your blood Phe levels when you start taking JAVYGTOR to see if the medicine is working
All patients with PKU who are being treated with JAVYGTOR should also be treated with a Phe-restricted diet, including dietary protein and Phe restriction
Your doctor should continue to monitor your blood Phe levels often during your treatment with JAVYGTOR to make sure that your blood Phe levels are not too high or too low. Frequent blood monitoring is recommended in the pediatric population
Avoid any dietary changes which may affect your blood Phe level. Follow your doctor’s instructions carefully and do not make any changes to your dietary Phe intake without first talking with your doctor. Even if you take JAVYGTOR and your Phe blood levels are not well controlled, you can develop severe neurologic problems
Tell your doctor as soon as possible if you are sick or have fever as this may increase your blood Phe level
Take JAVYGTOR exactly as your doctor tells you to
Do not take 2 doses in a day. If you take too much JAVYGTOR, call your doctor for advice or seek medical attention

Who Should Not Use JAVYGTOR Tablets for Oral Use and Powder for Oral Solution?

JAVYGTOR Tablets for Oral Use and Powder for Oral Solution are not recommended in patients with a history of anaphylaxis to Sapropterin Dihydrochloride or any of the ingredients in Sapropterin Dihydrochloride

What Should I Tell My Doctor Before Taking JAVYGTOR Tablets for Oral Use and Powder for Oral Solution?

Before taking JAVYGTOR Tablets for Oral Use or Powder for Oral Solution, tell your doctor if you:

Are allergic to Sapropterin Dihydrochloride or any of the ingredients in Sapropterin Dihydrochloride
Have poor nutrition or have loss of appetite
Are pregnant or plan to become pregnant
Are breastfeeding or plan to breastfeed

Provide your doctor with a complete list of medications you take, including prescription and over-the-counter medications, vitamins, and dietary or herbal supplements. JAVYGTOR can interact with other medications that you are taking. Especially tell your doctor if you take:

A medication that contains levodopa
An antifolate medication, such as methotrexate, phenobarbital, trimethoprim, valproic acid
Sildenafil (Revatio, Viagra), tadalafil (Adcirca, Cialis), vardenafil (Staxyn, Levitra)

Tell your doctor if you are unsure if your medication is one of the above listed. Always share your complete list of medications with your doctor and pharmacist.

What Are the Most Common Side Effects of JAVYGTOR Tablets for Oral Use and Powder for Oral Solution?

Headache
Runny nose and nasal congestion
Sore throat
Diarrhea
Vomiting
Cough

These are not all of the possible side effects of JAVYGTOR. Call your doctor for medical advice about side effects.

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