Makena

What is Makena?

Makena is a prescription hormone medicine (progestin) used in women who are pregnant and who have delivered a baby too early (preterm) in the past. Makena is used in these women to help lower the risk of having a preterm baby again. It is not known if Makena reduces the number of babies who are born with serious medical conditions or die shortly after birth. Makena is for women who are pregnant with one baby and who have had a preterm delivery of one baby in the past.

Makena is not intended for use to stop active preterm labor.

It is not known if Makena is safe and effective in women who have other risk factors for preterm birth.

Makena is not for use in women under 16 years of age.

Description

The active pharmaceutical ingredient in Makena is hydroxyprogesterone caproate, a progestin.

The chemical name for hydroxyprogesterone caproate is pregn-4-ene-3,20-dione, 17[(1-oxohexyl)oxy]. It has an empirical formula of C27H40O4 and a molecular weight of 428.60. Hydroxyprogesterone caproate exists as white to practically white crystals or powder with a melting point of 120°-124°C.

The structural formula is:

Makena is a clear, yellow, sterile, non-pyrogenic solution for intramuscular (vials) or subcutaneous (auto-injector) injection. Each 1.1 mL Makena auto-injector for subcutaneous use and each 1 mL single-dose vial for intramuscular use contains hydroxyprogesterone caproate USP, 250 mg/mL (25% w/v), in a preservative-free solution containing castor oil USP (30.6% v/v) and benzyl benzoate USP (46% v/v). Each 5 mL multi-dose vial contains hydroxyprogesterone caproate USP, 250 mg/mL (25% w/v), in castor oil USP (28.6%) and benzyl benzoate USP (46% v/v) with the preservative benzyl alcohol NF (2% v/v).

Mechanism of Action

Hydroxyprogesterone caproate is a synthetic progestin. The mechanism by which hydroxyprogesterone caproate reduces the risk of recurrent preterm birth is not known.

Who should not use Makena?

Makena should not be used if you have:

• blood clots or other blood clotting problems now or in the past
• breast cancer or other hormone-sensitive cancers now or in the past
• unusual vaginal bleeding not related to your current pregnancy
• yellowing of your skin due to liver problems during your pregnancy
• liver problems, including liver tumors
• high blood pressure that is not controlled

What should I tell my healthcare provider before using Makena?

Before you receive Makena, tell your healthcare provider about all of your medical conditions, including if you have:

• a history of allergic reaction to hydroxyprogesterone caproate, castor oil, or any of the other ingredients in Makena. See the end of this Patient Information leaflet for a complete list of ingredients in Makena.
• diabetes or pre-diabetes.
• epilepsy (seizures).
• migraine headaches.
• asthma.
• heart problems.
• kidney problems.
• depression.
• high blood pressure.

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

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

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

How should I use Makena?

• Do not give yourself Makena injections. A healthcare provider will give you the Makena injection 1 time each week (every 7 days) either:
  • in the back of your upper arm as an injection under the skin (subcutaneous), or
  • in the upper outer area of the buttocks as an injection into the muscle (intramuscular).
• You will start receiving Makena injections anytime from 16 weeks and 0 days of your pregnancy, up to 20 weeks and 6 days of your pregnancy.
• You will continue to receive Makena injections 1 time each week until week 37 (through 36 weeks and 6 days) of your pregnancy or when your baby is delivered, whichever comes first.

What are the possible side effects of Makena?

Makena may cause serious side effects, including:

• Blood clots. Symptoms of a blood clot may include;
  • leg swelling
  • redness in your leg
  • a spot on your leg that is warm to the touch
  • leg pain that gets worse when you bend your foot

  Call your healthcare provider right away if you get any of the symptoms above during treatment with Makena.

• Allergic reactions. Symptoms of an allergic reaction may include:
  • hives
  • itching
  • swelling of the face

  Call your healthcare provider right away if you get any of the symptoms above during treatment with Makena.

• Decrease in glucose (blood sugar) tolerance. Your healthcare provider will need to monitor your blood sugar while taking Makena if you have diabetes or pre-diabetes.
• Your body may hold too much fluid (fluid retention).
• Depression.
• Yellowing of your skin and the whites of your eyes (jaundice).
• High blood pressure.

The most common side effects of Makena include:

• pain, swelling, itching or a hard bump at the injection site
• hives
• itching
• nausea
• diarrhea

Call your healthcare provider if you have the following at your injection site:

• increased pain over time
• oozing of blood or fluid
• swelling

Other side effects that may happen more often in women who receive Makena include:

• Miscarriage (pregnancy loss before 20 weeks of pregnancy)
• Stillbirth (fetal death occurring during or after the 20th week of pregnancy)
• Hospital admission for preterm labor
• Preeclampsia (high blood pressure and too much protein in your urine)
• Gestational hypertension (high blood pressure caused by pregnancy)
• Gestational diabetes
• Oligohydramnios (low amniotic fluid levels)

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Makena. 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.

General information about the safe and effective use of Makena

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Makena for a condition for which it was not prescribed. Do not give Makena to other people, even if they have the same symptoms you have. It may harm them.

This leaflet summarizes the most important information about MAKENA. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Makena that is written for health professionals.

How should I store Makena?

• Makena auto-injector for subcutaneous use:
  • Store the auto-injector at room temperature between 68°F to 77°F (20°C to 25°C).
  • Do not refrigerate or freeze.
  • Protect the auto-injector from light.
  • Store the auto-injector in its box.
• Makena vial for intramuscular use:
  • Store the vial at room temperature between 68°F to 77°F (20°C to 25°C).
  • Do not refrigerate or freeze.
  • Protect the vial from light.
  • Store the vial in its box in an upright position.

Keep Makena and all medicines out of the reach of children.

What are the ingredients in Makena?

Active ingredient: hydroxyprogesterone caproate

Inactive ingredients: castor oil and benzyl benzoate. 5 mL multi-dose vials also contain benzyl alcohol (a preservative).

LabePRINCIPAL DISPLAY PANEL – NDC 64011-301-03 – 1.1 ML AUTO-INJECTOR LABEL