• Mycapssa is an oral prescription medicine used in the long-term maintenance treatment of acromegaly in people for whom initial treatment with octreotide or lanreotide has been effective and tolerated.
• It is not known if this medicine is safe and effective in children.

• Take Mycapssa exactly as your healthcare provider tells you to take it.
• Take the capsules with a glass of water on an empty stomach.
• Take the capsules at least 1 hour before a meal or at least 2 hours after a meal (for example, you could take your morning dose 1 hour before breakfast and your evening dose at bedtime).
• Swallow the capsules whole. Do not crush or chew the capsules before swallowing.

Do not take Mycapssa if you:

• are allergic to octreotide acetate or any of the other ingredients. Mycapssa can cause a serious allergic reaction including anaphylactic shock. Stop treatment right away and get emergency help if you have any of these symptoms:
  • swelling of your tongue, throat, lips, eyes or face
  • severe itching of the skin with rash or raised bumps
  • chest pain
  • trouble swallowing or breathing
  • feeling faint
  • rapid heart beat

See the end of this page for a complete list of ingredients.

Before you take Mycapssa

Before you take Mycapssa, tell your healthcare provider about all of your medical conditions, including if you:

• have liver cirrhosis or liver problems
• have kidney problems
• are pregnant or plan to become pregnant. It is not known if Mycapssa will harm your unborn baby. Mycapssa may increase your chance of becoming pregnant.
• are breastfeeding or plan to breastfeed. It is not known if Mycapssa passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take Mycapssa.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Mycapssa may affect the way other medicines work, and other medicines may affect how Mycapssa works.

Especially tell your healthcare provider if you take oral contraceptives. Use an alternative non-hormonal method of contraception or a back-up method while taking Mycapssa.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

• gallbladder problems. Mycapssa may cause problems with the gallbladder. Tell your healthcare provider if you have sudden pain in your upper right stomach (abdomen), sudden pain in your right shoulder or between your shoulder blades, yellowing of your skin or the whites of your eyes, fever with chills, nausea
• blood sugar problems. Mycapssa may cause you to have high blood sugar (hyperglycemia), low blood sugar (hypoglycemia), or diabetes. Tell your healthcare provider if you have problems with high or low blood sugar. Your healthcare provider will check your blood sugar when you start taking Mycapssa or when your dose is changed.
• thyroid problems. Mycapssa may keep your thyroid from releasing thyroid hormones leading to hypothyroidism. Your thyroid function will be checked regularly during treatment.
• heart rhythm problems. Tell your healthcare provider if you have an irregular heartbeat (your heart is not beating normally).
• low vitamin B12 levels in your blood. Your healthcare provider may check your vitamin B12 levels during treatment.

The most common side effects include:

• headache
• nausea
• diarrhea
• joint pain
• weakness
• sweating a lot

These are not all the possible side effects. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.