Milprosa Side Effects Center

Last updated on RxList: 5/6/2020
Milprosa Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Milprosa?

Milprosa (progesterone) is a female hormone progesterone used to support embryo implantation and early pregnancy (up to 10 weeks post-embryo transfer) by supplementation of corpus luteal function as part of an Assisted Reproductive Technology (ART) treatment program for infertile women.

What Are Side Effects of Milprosa?

Side effects of Milprosa include:

  • headache,
  • vaginal discharge,
  • nausea,
  • breast tenderness,
  • post procedural discomfort,
  • abdominal distension,
  • abdominal pain,
  • pelvic pain, and
  • constipation

Dosage for Milprosa

The dose of Milprosa is one vaginal system inserted initially on the day after oocyte retrieval and then replaced weekly, continuing for up to 10 weeks total duration.

Milprosa In Children

The safety and effectiveness of Milprosa have not been established in pediatric patients. Milprosa is not intended for pediatric use.

What Drugs, Substances, or Supplements Interact with Milprosa?

Milprosa may interact with other medicines such as:

  • drugs known to induce the hepatic CYP3A4 enzyme (such as rifampin, carbamazepine) and
  • other vaginal products (such as antifungal products, vaginal lubricants, diaphragms and condoms)

Tell your doctor all medications and supplements you use.

Milprosa During Pregnancy and Breastfeeding

Milprosa is indicated to support embryo implantation and early pregnancy as part of an assisted reproductive technology treatment program in vitro fertilization (IVF) with or without intracytoplasmic sperm injection (ICSI) and embryo transfer for infertile women. Maternal risks are discussed throughout the labeling. Detectable amounts of Milprosa have been identified in the milk of nursing mothers. The effect of this on the nursing infant has not been determined. Consult your doctor before breastfeeding.

Additional Information

Our Milprosa (progesterone) Vaginal System Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

Men and women are equally likely to have fertility problems. See Answer
Milprosa Professional Information

SIDE EFFECTS

The following serious adverse reactions are discussed elsewhere in the labeling:

  • Cardiovascular or Cerebrovascular Disorders [see WARNINGS AND PRECAUTIONS]
  • Depression [see WARNINGS AND PRECAUTIONS]
  • Toxic Shock Syndrome [see WARNINGS AND PRECAUTIONS]

Clinical Study Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety data described in Table 1 reflect exposure to MILPROSA (up to 10 weeks) in 647 infertile women (80% Caucasian, 8% African-American, 5% Hispanic, 5% Asian) in a single prospective, randomized, active concurrently-controlled clinical trial of progesterone supplementation in women undergoing in-vitro fertilization (IVF) in the U.S. [see Clinical Studies]. Adverse reactions that occurred at a rate greater than or equal to 2% in the MILPROSA treatment group are summarized in Table 1.

Table 1: Number and Frequency of Adverse Reactions in Women Treated with MILPROSA in an Assisted Reproductive Technology Study (≥2%)

Preferred TermMILPROSA
(N=647)
Headache44 (7%)
Vaginal discharge26 (4%)
Nausea25 (4%)
Breast tenderness24 (4%)
Post procedural discomfort24 (4%)
Abdominal distension22 (3%)
Abdominal pain19 (3%)
Pelvic pain19 (3%)
Constipation17 (3%)

Additional safety data following exposure to MILPROSA was collected in a multi-center, non-comparative, open-label, single-arm study of women undergoing Assisted Reproductive Technology in the U.S. The population consisted of 254 infertile women 18-34 years of age (83% Caucasian, 7% African-American, 9% Asian,1% American Indian) who were exposed up to 10 weeks. The adverse reaction profile was consistent with previous observations.

Adverse reactions associated with other drugs containing progesterone include bloating, mood swings, irritability, and drowsiness.

Read the entire FDA prescribing information for Milprosa (Progesterone Vaginal System)

SLIDESHOW

Fertility Options: Types, Treatments, and Costs See Slideshow

© Milprosa Patient Information is supplied by Cerner Multum, Inc. and Milprosa Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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