skin due to liver problems during your pregnancy
Have liver problems, including liver tumors
Have uncontrolled high blood pressure
What should I tell my healthcare provider before receiving Makena?
Before you receive Makena, tell your healthcare provider if you have:
An allergy to hydroxyprogesterone caproate, castor oil, or any of the other ingredients in Makena. See the end of this patient leaflet for a complete list of the ingredients in Makena.
Diabetes or prediabetes
Epilepsy
Migraine headaches
Asthma
Heart problems
Kidney problems
Depression
High blood pressure
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription 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 medication.
How should I receive Makena?
Do not give yourself Makena injections. A healthcare professional will give you the Makena injection into your hip area (upper outer area of the buttocks) once a week (every 7 days).
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 once weekly until week 37 of your pregnancy or when your baby is delivered, whichever happens first.
Makena comes in ready-to-use vials. There are 5 doses of medicine in each vial. Your healthcare professional should give you only one dose (1 mL) of Makena as prescribed each week.
Makena should be used within 5 weeks after the first use.
It is very important that you do not miss a dose of Makena and that you continue to receive the medicine once a week. If you miss a dose, talk to your healthcare provider for specific directions on how to get back on schedule.
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 touch
Leg pain that worsens when you bend your foot
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.
Depression
Yellowing of your skin and the whites of your eyes
The most common side effects of Makena include:
Pain, swelling, itching, bruising 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
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.
In a clinical study, certain complications or events associated with pregnancy occurred more often in women who received Makena compared to women who did not receive Makena, including:
Miscarriage (pregnancy loss before 20 weeks of pregnancy)
Stillbirth (fetal death occurring 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 |
