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PKU & Pregnancy
Keep Phe low for a healthy baby
Staying on a low-Phe diet is a must, especially if you're thinking of becoming a mom. Every new parent wants what is best for their baby – the chance to be all they can possibly be. If you have PKU, talk to your doctor before you actively try to have a baby. You need to take action right away to give your child a healthy, happy start in life.
High Phe during pregnancy is harmful to the baby
High Phe during pregnancy harms the unborn baby's brain. It puts an unborn baby at very high risk for serious problems. The risk of mental retardation is over 90%. The baby may have a small head or odd facial features. Other problems, like heart disease, are common too.2,20
These problems are very similar to the problems of babies born to women who drink a lot of alcohol during pregnancy.2
High Phe when you are pregnant can affect the baby's intelligence for life. A study compared babies of women who had high Phe during pregnancy with babies of women who had Phe under control while they were pregnant. At age 2, the high Phe babies did worse on tests than the other kids. By age 4, they were even more behind.20
The good news is that women with PKU can have healthy, happy babies. But it is very important to make sure you have Phe under control before you get pregnant, or as soon as you know you are pregnant. The earlier you have Phe under control, the better it is for your baby.2,20
Also, the lower you get your Phe, the better it is for you – and your baby.2
Remember:
- Lower is better*
- Sooner is better
Be extra careful with a second pregnancy
Research finds that women with PKU usually have less Phe control during later pregnancies than during the first one.13 But Phe control is important to every baby! Even when you already have one baby to take care of, you need to take good care of yourself and your unborn second baby by keeping Phe low.
KUVAN and pregnancy
Good control of Phe levels before and during pregnancy is essential because high Phe is toxic to an unborn child. KUVAN is a pregnancy category C medication, which means that KUVAN should be used only if clearly needed. If you are planning to become pregnant or are already pregnant, talk to your doctor immediately to find out if KUVAN is right for you.
Several pregnant women who took KUVAN have delivered normal, healthy babies, free from the effects of Maternal PKU Syndrome. To date, there are no adequate and well-controlled studies of KUVAN in pregnant women. Women who are exposed to KUVAN during pregnancy are encouraged to enroll in the KUVAN patient registry established by BioMarin. This registry could aid in determining the effects of KUVAN during pregnancy. To register, contact the BioMarin Patient and Physician Support (BPPS) by calling 1-866-906-6100, or sending a message.
* Lower is better until you get Phe into the normal range of 1-2 mg/dL. Going lower than 1-2 mg/dL can be unhealthy. Talk with your doctor about the right target range for you.1,2
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Indication
KUVAN
® (sapropterin dihydrochloride) Tablets are approved to reduce blood Phe levels in patients with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria (PKU). KUVAN is to be used in conjunction with a low-Phe diet.
Important Safety Information
High blood Phe levels are toxic to the brain and can lead to lower intelligence and decrease in the ability to focus, remember and organize information. Any change you make to your diet may impact your blood Phe level. Follow your doctor's instructions carefully. Your doctor and dietitian will continue to monitor your diet and blood Phe levels throughout your treatment with KUVAN.
If you have a fever, or if you are sick, your Phe level may go up. Tell your doctor and dietitian as soon as possible so they can see if they have to adjust your treatment to help keep your blood Phe levels in the desired range.
KUVAN is a prescription medicine and should not be taken by people who are allergic to any of its ingredients. Tell your doctor if you have ever had liver or kidney problems, are nursing or pregnant or may become pregnant, have poor nutrition or are anorexic. Your doctor will decide if KUVAN is right for you. Tell your doctor about all the medicines you take.
The most common side effects reported when using KUVAN are headache, diarrhea, abdominal pain, upper respiratory tract infection (like a cold), throat pain, vomiting, and nausea.
To report SUSPECTED ADVERSE REACTIONS, contact BioMarin Pharmaceutical Inc. at 1-866-906-6100, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please read the full Patient Information by clicking here.
