hydroxyprogesterone
Hydroxyprogesterone is an injection used to help regulate menstrual periods and treat uterine cancer. It's given as a shot into your buttocks muscle, and can cause pain or swelling at the injection site as a side effect.
Please note: As of April 2023, hydroxyprogesterone is no longer approved by the FDA to lower chance of pre-term labor.
What is Hydroxyprogesterone?
What is Hydroxyprogesterone used for?
- Lack of menstrual periods due to hormone imbalance
- Irregular periods due to hormone imbalance
- Advanced uterine cancer
- Testing for natural estrogen production
How Hydroxyprogesterone works
Hydroxyprogesterone is a progestin that acts like the natural sex hormone progesterone. The progesterone levels in your body help regulate the lining of your uterus. By helping to balance your natural progesterone levels, hydroxyprogesterone regulates menstrual periods. In uterine cancer, the medication can help block the growth of cancerous cells of the uterine lining.
Drug facts
Side effects of Hydroxyprogesterone
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Pain where the medication was injected (35%)
- Swelling where the medication was injected (17%)
- Hives (12%)
Less Common Side Effects
- Itchiness
- Redness where the medication was injected
- Nausea
- Diarrhea
Hydroxyprogesterone serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Allergic reactions
- Blood clot: Sudden, severe pain and swelling in your leg or arm, chest pain, sudden, severe headaches, trouble breathing, sudden changes in your speech or vision
More on Hydroxyprogesterone side effects
Pros and cons of Hydroxyprogesterone
Pros
- Only needs to be given once per menstrual cycle to treat irregular periods
- Other than injection site discomfort, not many side effects
Cons
- Only available as an injection that must be given at your provider's office
- Can't be used if you have liver problems
Pharmacist tips for Hydroxyprogesterone
- Hydroxyprogesterone has to be given by a trained healthcare provider. It's not safe to try to give yourself the injection at home.
- Hydroxyprogesterone needs to be given on time in order to work properly, regardless of what condition you are using it for. Be sure to go to your injection appointments as instructed by your provider.
- After your injection, contact your provider if you notice increased discomfort over time, oozing of blood or fluid, or inflammatory reactions at the injection site. This could be signs of an infection.
- Make sure to tell your provider about your full medical history before starting treatment with hydroxyprogesterone, especially if you have a history of depression because this medication can make depression worse.
- Sometimes, hydroxyprogesterone can cause you to experience a cough, tight chest, or trouble breathing. This is more likely to happen if your provider gives you a high dose. If you experience trouble breathing after your hydroxyprogesterone shot, call your provider right away.
Common questions about Hydroxyprogesterone
No, Makena (hydroxyprogesterone) and its generics are no longer approved to prevent preterm labor as of April 2023. The FDA removed this use because the manufacturer of this medication wasn't able to show that it worked well to help newborns. Hydroxyprogesterone is still approved to help regulate menstrual periods and treat uterine cancer.
Hydroxyprogesterone can cause weight changes, meaning it can cause weight gain and weight loss. If you experience changes in your body weight after your Hydroxyprogesterone shot, discuss your concerns with your provider.
Hydroxyprogesterone can raise your blood sugar levels. This can be dangerous, especially if you have diabetes. Because of this risk, your provider might have you check your blood sugar levels more often during Hydroxyprogesterone therapy.
Research in people who received Hydroxyprogesterone at 16 weeks of pregnancy or later show that it isn't likely to cause any serious birth defects. On the other hand, clinical trials suggest that though rare, Hydroxyprogesterone might raise the risk of miscarriage compared with placebo. Keep in mind that Hydroxyprogesterone is no longer approved for use in pregnancy to prevent early labor. If you've questions about Hydroxyprogesterone and pregnancy, talk with your provider.
People who took progestins, like Hydroxyprogesterone, have developed blood clots in different parts of the body, including the brain and lungs. Get medical help right away if you develop sudden, severe pain and swelling in your leg or arm, severe headaches, trouble breathing, or sudden changes in your speech or vision.
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Risks and warnings for Hydroxyprogesterone
Hydroxyprogesterone can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Blood clots
- Risk factors: Personal or family history of blood clots | High blood pressure | Diabetes | High cholesterol | Smoking | People who are overweight | Systemic lupus erythematosus (SLE)
Hydroxyprogesterone can raise your risk of blood clots, which can be very dangerous. While there are several conditions that can raise this risk even further, smoking and a history of blood clots are two of the biggest risk factors. Be sure to discuss all your past and present medical conditions with your provider before starting hydroxyprogesterone. Call 911 or get immediate medical attention if you have pain in your legs or arms, chest pain, sudden, severe headaches, trouble breathing, or sudden changes in your speech or vision.
High blood sugar
- Risk factors: Diabetes | Pre-diabetes | Metabolic syndrome
Hydroxyprogesterone can raise your blood sugar levels. If you are using this medication while pregnant, this raises your risk of developing diabetes during your pregnancy (gestational diabetes). If you have diabetes, hydroxyprogesterone makes it more difficult to control your blood sugar. Let your provider know if you have diabetes or any problems with your blood sugar levels before you start using this medication. You might need to monitor your blood sugar levels more often while using hydroxyprogesterone.
Fluid build-up
- Risk factors: History of heart failure | History of kidney problems
Hydroxyprogesterone can cause extra fluid to build up in your body, especially in your legs, ankles, and feet. Fluid build-up is more likely to happen if you have certain conditions, like heart failure or kidney problems. If you know you have problems with fluid build-up or swelling, tell your provider before you start using hydroxyprogesterone. Call your provider or seek medical help right away if you notice unexplainable swelling, quick weight gain (more than 3 pounds in a day or 5 pounds in a week), or sudden trouble breathing.
Allergic reactions
Allergic reactions to hydroxyprogesterone are possible, including life-threatening problems like anaphylaxis or airway swelling. Call 911 if this happens. If you notice hives, a rash, swelling of the lips or tongue, or difficulty breathing after receiving your dose of hydroxyprogesterone, get medical help right away.
Hydroxyprogesterone dosage
Typical dosage for Hydroxyprogesterone
- Lack of or irregular menstrual periods:
- Single dose treatment or cyclic therapy (taking estrogen therapy): Your provider will inject 375 mg into your buttock muscle one time.
- Cyclic therapy (not taking estrogen therapy): Your provider will inject 250 mg into your buttock muscle on day 15 of the 28-day cycle planned by you and your provider. As part of treatment, provider will also give you estradiol valerate (Delestrogen) on different days of the cycle.
- Advanced uterine cancer: Your provider will inject 1,000 mg into your buttock muscle one or more times a week. Use no more 7,000 mg per week.
- Testing for estrogen production: Your provider will inject 250 mg into your buttock muscle one time. If your body produces estrogen, you can expect a menstrual period 7 to 14 days after the injection. Your provider can order another injection 28 days later if needed.
Hydroxyprogesterone contraindications
Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Hydroxyprogesterone will not be safe for you to take.
- Current or history of blood clots
- Known, suspected, or history of breast cancer or other hormone-sensitive cancer
- Undiagnosed abnormal vaginal bleeding unrelated to pregnancy
- Past pregnancy where the unborn baby stopped developing (missed abortion)
- Liver problems or liver tumors
What are alternatives to Hydroxyprogesterone?
