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Important Safety Information

What is Macrilen?

Macrilen (pronounced ma-kri-len) (macimorelin) is a prescription oral solution that is used to test for adult growth hormone deficiency (AGHD).

What should you know about Macrilen?

What are the most common side effects with Macrilen?

The most common side effects were changed sense of taste, dizziness, headache, fatigue, nausea, hunger, diarrhea, upper respiratory tract infection, feeling hot, excessive sweating, sore nose and throat, and decreased heart rate.

These are not all of the possible side effects of Macrilen. Call your healthcare provider for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch/ or call 1-800-FDA-1088.

Please see Full Prescribing Information.

What is growth hormone (GH)?

GH is a chemical substance that is released from the pituitary gland.

  • GH keeps your bones, fat, and muscles in balance
  • Even after you stop growing in childhood, GH is important to support healthy tissue and organs as an adult
  • GH also impacts brain function

GH is released in pulses, so measuring your blood for too little GH (also known as a deficiency) may be hard.

What is GH deficiency?

GH deficiency can cause damage to your body, including your heart and muscles, and can affect your mental health.

What is Adult Growth Hormone Deficiency (AGHD)?

People who have AGHD can include those who were GH deficient as children and become adults with AGHD, or adults who become GH deficient. In adults, GH deficiency can develop when your pituitary gland or hypothalamus is damaged due to tumors, surgery, radiation, or traumatic brain injury. GH is important for adults to support healthy tissue and organs.

Signs and symptoms of AGHD

There are many signs and symptoms related to AGHD. Some of them overlap with other conditions, which can make it hard to tell whether you have AGHD. They may include

  • Mood changes such as depression, anxiety, and social isolation
  • Decrease in muscle and exercise
  • Impaired concentration
  • Loss of memory
  • Osteoporosis
  • Hair and skin issues
  • Fatigue
  • Sleeping issues
  • Difficulty with sexual relationships
  • Weight gain (usually around the stomach)
  • Increase in bad cholesterol (LDL)
  • Decrease in good cholesterol (HDL)
  • Greater sensitivity to hot and cold temperatures

If these signs and symptoms seem familiar to you, schedule an appointment with a healthcare professional. It’s important to prepare yourself with the right questions beforehand.

Testing for AGHD

Because it is difficult to measure GH in your blood due to normal variations in GH levels, many healthcare professionals will perform tests that stimulate your pituitary gland. These tests cause your pituitary gland to release GH, so your healthcare professional can tell whether your GH levels are too low.

If your healthcare professional thinks that your GH levels are too low, you may be asked to schedule a GH stimulation test to help determine whether you are able to produce GH. This type of test is the only way to diagnose AGHD. There are different types of tests available. Macrilen is the first and only FDA-approved oral test for the diagnosis of AGHD.

What is Macrilen?

Macrilen is a prescription drug that you drink to help your healthcare professional diagnose AGHD. Macrilen comes as granules that are mixed with water to form the solution that you drink. The test lasts 90 minutes. When it’s finished, there is no downtime, so you can continue with your day.

How does Macrilen work?

What to expect at your doctor’s office

Macrilen dosing is based on your weight. Once you have been weighed, the dose is ordered by your healthcare professional. When you come in for your test, you will be weighed again so that the proper dosage can then be determined. The Macrilen test is then completed in 3 main steps.

1

Drink

You must drink the entire solution within 30 seconds.

2

Draw

Your blood will be drawn 4 times–at 30, 45, 60, and 90 minutes after you drink the Macrilen solution.

3

Diagnose

Your blood samples will be tested in the lab, and a healthcare professional will review your results to determine whether you have AGHD.

What to keep in mind before you take the Macrilen test

If your healthcare professional decides to test you for AGHD with Macrilen, it is important to make sure that you have completed a washout period. This means that for a certain period of time you must stop taking medications that may affect the accuracy of the test. Ask your healthcare professional to check your medications before taking the test.

  • Tell your healthcare professional if you are breastfeeding, pregnant, or trying to get pregnant
  • Talk to your healthcare professional about all the medications you are taking. You might need to stop taking certain medications that could affect the test results
  • Set an alarm or reminder on your phone for at least 8 hours before the test so you remember to fast (do not eat or drink anything but water)

What are the most common side effects with Macrilen?

The most common side effects in 3% to 5% of patients include changed sense of taste, dizziness, headache, fatigue, nausea, and hunger.

Dedicated to helping you

We provide a wide range of support services for people being tested with Macrilen.

Please call Strongbridge CareConnection at 1-844-MAC-AGHD (1-844-622-2443) for more information.

Product coverage assistance

  • Patient benefit verification and coverage information
  • Medical necessity and appeal resources
  • If you are prescribed Macrilen by a healthcare professional, the next step is to verify your insurance coverage
  • You may receive a call from your specialty pharmacy asking you to provide your insurance coverage information*

Patient access and affordability

  • Strongbridge is committed to supporting patient access to Macrilen through the Macrilen Co-pay Savings Program, which may help to lower your out-of-pocket costs for Macrilen
  • If you do not have health insurance or do not have coverage for Macrilen, you may be eligible to receive Macrilen at no cost

*For patients who have commercial or private health insurance.

AGHD community connection

Strongbridge is proud to partner with the following organizations to make sure patients with AGHD and their families and caregivers have access to the information and support they need. Please visit the following organizations’ websites for more information on AGHD.

Important Safety Information

What is Macrilen?

Macrilen (pronounced ma-kri-len) (macimorelin) is a prescription oral solution that is used to test for adult growth hormone deficiency (AGHD).

What should you know about Macrilen?

  • Taking Macrilen with certain other medications may cause irregular changes to your heart rhythm. Before taking Macrilen, tell your healthcare provider about all your medications, as you may need to temporarily stop taking some medications before you take Macrilen.
  • Some medications may cause a false positive result when taken with Macrilen. Before taking Macrilen, tell your healthcare provider about all the medications you take, including growth hormone.
  • Tell your healthcare provider if you were recently diagnosed with hypothalamic disease, as this can cause a false negative result with Macrilen.
  • You will need to fast (go without food) for at least 8 hours before taking Macrilen.

What are the most common side effects with Macrilen?

The most common side effects were changed sense of taste, dizziness, headache, fatigue, nausea, hunger, diarrhea, upper respiratory tract infection, feeling hot, excessive sweating, sore nose and throat, and decreased heart rate.

These are not all of the possible side effects of Macrilen. Call your healthcare provider for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch/ or call 1-800-FDA-1088.

Please see Full Prescribing Information.

900 Northbrook Drive, Suite 200

Trevose, PA 19053

United States

Phone: +1 610-254-9200

macrilen_info@strongbridgebio.com