OCLAIZ is a prescription medicine used for the maintenance treatment of acromegaly in adults who have responded to and tolerated treatment with other similar medications, such as octreotide or lanreotide.

Do not use OCLAIZ if you are allergic to octreotide or any of the ingredients in OCLAIZ. Severe allergic reactions, including anaphylactic shock, have occurred in people receiving octreotide.

What should I tell my healthcare provider before taking OCLAIZ?

Before taking OCLAIZ, tell your healthcare provider about all your medical conditions, including if you:

• have gallbladder problems
• have blood sugar control problems (low blood sugar or high blood sugar)
• have problems with your heart rate
• are pregnant or plan to become pregnant. It is not known if OCLAIZ might impact your pregnancy.
• are breastfeeding or plan to breastfeed. It is not known if OCLAIZ passes into breast milk. Talk to your healthcare provider about the best way to feed your baby if you take OCLAIZ.

Tell your healthcare provider about all the medicines you take,
including prescription medications, such as cyclosporine, insulin or other diabetes medicines, medicines that lower your heart rate such as beta-blockers, or bromocriptine. OCLAIZ may affect the way other medicines work, and other medicines may affect how OCLAIZ works.

What are the possible side effects of OCLAIZ?

• Gallbladder problems: OCLAIZ may cause problems with your gallbladder. Tell your healthcare provider if you have sudden pain in the upper right stomach area, sudden pain in your right shoulder or between your shoulder blades, yellowing of your skin or the whites of your eyes, or pale stools.
• Blood sugar problems: OCLAIZ may potentially cause high blood sugar (hyperglycemia), including diabetes, or low blood sugar (hypoglycemia). Your healthcare provider will check your blood sugar levels regularly, and you may need changes in your diabetes medication.
• Thyroid problems: OCLAIZ may keep your thyroid from releasing thyroid hormones, leading to hypothyroidism (an underactive thyroid). Your thyroid function may be checked periodically during your treatment.
• Heart rate problems: Tell your healthcare provider if your heart is not beating normally.
• Changes in fat absorption: OCLAIZ may cause your body to have problems with absorbing dietary fats. Tell your healthcare provider if you have any new or worsening symptoms, including fatty stools, changes in the color of your stools, loose stools, stomach (abdominal) bloating, or weight loss.
• Changes in Vitamin B₁₂ levels: Lower vitamin B12 levels have been observed in some patients receiving octreotide therapy, including OCLAIZ. Your healthcare provider may check your vitamin B12 levels during treatment with OCLAIZ.

The most common side effects of OCLAIZ include joint pain, headache, itchiness, abdominal pain, and back pain. These are not all the possible side effects of OCLAIZ. For more information, ask your healthcare provider or pharmacist.

You are encouraged to report negative side effects to Camurus at 1-877-226-0005 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.