Sapropterin oral solution

What is this medicine?

SAPROPTERIN (SAP roe TER in) works to lower phenylalanine levels in the blood. It is used with a special diet to treat phenylketonuria. This medicine is not a cure.

How should I use this medicine?

Take this medicine by mouth with food. Follow the directions on the prescription label. Dissolve powder in water or apple juice. Talk to your health care professional about how much water or apple juice you should use. The powder should dissolve quickly and completely. Drink within 30 minutes of mixing. The powder may also be stirred into a small amount of apple sauce or pudding. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 1 month of age for selected conditions, precautions do apply.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• black or bloody stools, blood in the vomit

• breathing problems

• feeling faint or lightheaded, falls

• hyperactivity, being fidgety or talking or moving around too much

• severe abdominal pain

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• cough

• diarrhea

• headache

• nausea, vomiting

• sore throat

• runny or congested nose

What may interact with this medicine?

• avanafil

• levodopa

• methotrexate

• pemetrexed

• pyrimethamine

• sildenafil

• tadalafil

• vardenafil

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Take only one dose each day. Do not take double or extra doses.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Store this medicine in the original container. Keep the container tightly closed. Throw away any unused medicine after the expiration date.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• eating disorder like anorexia, bulimia

• fever

• infection

• kidney disease

• liver disease

• seizures

• an unusual or allergic reaction to sapropterin, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

What should I watch for while using this medicine?

Your condition will be monitored carefully while you are receiving this medicine. Visit your doctor for regular check ups and for blood tests. It may take up to 4 weeks for your body to respond to this medicine.

Tell your doctor or health care professional if your symptoms do not start to get better or if they get worse.

You will need to be on a special diet while you are taking this medicine. Talk with your health care professional before making any changes to your diet.