Follistim AQ Cartridge Side Effects Center

Last updated on RxList: 2/22/2022
Follistim AQ Cartridge Side Effects Center

What Is Follistim AQ Cartridge?

Follistim AQ Cartridge (follitropin beta injection) contains human follicle-stimulating hormone (hFSH) and is used to treat infertility in women that is not due to primary ovarian failure. Follistim AQ Cartridge is also used to stimulate sperm production in men.

What Are Side Effects of Follistim AQ Cartridge?

Common side effects of Follistim AQ Cartridge include:

  • headache,
  • abdominal bloating,
  • stomach pain,
  • constipation,
  • diarrhea,
  • nausea,
  • pelvic pain or discomfort,
  • breast tenderness or pain,
  • vaginal hemorrhage,
  • injection site reaction (redness, pain, irritation, or bruising), dizziness, numbness or tingly feeling,
  • runny or stuffy nose,
  • sore throat,
  • acne, or
  • skin rash

Dosage for Follistim AQ Cartridge

The dosing scheme of Follistim AQ Cartridge is stepwise and is individualized for each woman.

What Drugs, Substances, or Supplements Interact with Follistim AQ Cartridge?

Follistim AQ Cartridge may interact with other drugs. Tell your doctor all medications and supplements you use.

Follistim AQ Cartridge During Pregnancy or Breastfeeding

Follistim AQ Cartridge should not be used during pregnancy. It is unknown if this drug is excreted in human milk. Consult your doctor before breastfeeding.

Additional Information

Our Follistim AQ Cartridge (follitropin beta injection) 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.

QUESTION

Men and women are equally likely to have fertility problems. See Answer
Follistim AQ Cartridge Professional Information

SIDE EFFECTS

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

  • Ovarian Hyperstimulation Syndrome [see WARNINGS AND PRECAUTIONS]
  • Atelectasis [see WARNINGS AND PRECAUTIONS]
  • Thromboembolism [see WARNINGS AND PRECAUTIONS]
  • Ovarian Torsion [see WARNINGS AND PRECAUTIONS]
  • Multi-fetal Gestation and Birth [see WARNINGS AND PRECAUTIONS]
  • Congenital Anomalies [see WARNINGS AND PRECAUTIONS]
  • Ectopic Pregnancy [see WARNINGS AND PRECAUTIONS]
  • Spontaneous Abortion [see WARNINGS AND PRECAUTIONS]

Clinical Study Experience

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

Ovulation Induction

In a single cycle, multi-center, assessor-blind, parallel group, comparative study, a total of 172 chronic anovulatory women who had failed to ovulate and/or conceive with clomiphene citrate therapy, were randomized and treated with Follistim (105) or a urofollitropin comparator. Adverse reactions with an incidence of greater than 2% in either treatment group are listed in Table 2.

Table 2: Common Adverse Reactions Reported at a Frequency of ≥2% in an Assessor-Blind, Comparative Study of Anovulatory Women Receiving Ovulation Induction

System Organ Class/Adverse Reactions Treatment Number (%) of Women
Follistim
N=105
n (%)
Comparator
N=67
n (%)
Gastrointestinal disorders
Abdominal discomfort 3 (2.9) 1(1.5)
Abdominal pain 3 (2.9) 2 (3.0)
Abdominal pain lower 3 (2.9) 1(1.5)
Reproductive system and breast disorders
Ovarian cyst 3 (2.9) 2 (3.0)
Ovarian hyperstimulation syndrome 8 (7.6) 3 (4.5)
General disorders and administration site conditions
Pyrexia 0 (0.0) 2 (3.0)

Adverse reactions reported commonly (greater than or equal to 2% of women treated with Follistim) in other ovulation induction clinical trials were headache, abdominal distension, constipation, diarrhea, nausea, pelvic pain, uterine enlargement, vaginal hemorrhage and injection site reaction.

In Vitro Fertilization/Intracytoplasmic Sperm Injection

In a single cycle, multi-center, double-blind, parallel group, comparative study, a total of 1509 women were randomized to receive controlled ovarian stimulation with either Follistim AQ Cartridge (751 women were treated with Follistim AQ Cartridge) or a comparator and pituitary suppression with a gonadotropin releasing hormone (GnRH) antagonist as part of an in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) cycle. Table 3 lists adverse reactions with an incidence of greater than 2% in the group of women treated with Follistim AQ Cartridge.

Table 3: Common Adverse Reactions Reported at a Frequency of ≥2% in a Randomized, Double-blind, Active-controlled, Comparative Study of Normal Ovulatory Women Undergoing Controlled Ovarian Stimulation as Part of an In Vitro Fertilization or Intracytoplasmic Sperm Injection Cycle

System Organ Class/Adverse Reactions Follistim AQ Cartridge Treatment
N = 751
n* (%)
Nervous System disorders
Headache 55 (7.3%)
Gastrointestinal disorders
Nausea 29 (3.9%)
Reproductive system and breast disorders
Ovarian Hyperstimulation Syndrome 48 (6.4%)
Pelvic discomfort 62 (8.3%)
Pelvic Pain 41 (5.5%)
General disorders and Administration site conditions
Fatigue 17 (2.3%)
* n = number of women with the adverse reaction

Induction Of Spermatogenesis

In an open-label, non-comparative clinical trial, 49 men with hypogonadotropic hypogonadism were enrolled to receive pretreatment with hCG, followed by combination therapy with hCG and Follistim for induction of spermatogenesis. Of the 49 men, 30 received weekly Follistim doses of 450 international units; 24 of these 30 men received a total of 48 weeks of treatment with Follistim. Adverse reactions occurring with an incidence of greater than 2% in the 30 men treated with Follistim are listed in Table 4.

Table 4: Common Adverse Reactions Reported at a Frequency of ≥2% in an Open-Label Clinical Trial in Men with Hypogonadotropic Hypogonadism

System Organ Class/Adverse Reactions Follistim Treatment
N=30 n (%)
Nervous system disorders
Headache 2 (6.7)
General disorders and administration site disorders
Injection site reaction 2 (6.7)
Injection site pain 2 (6.7)
Skin and cutaneous tissue disorders
Acne 2 (6.7)
Rash 1 (3.3)
Reproductive system and breast disorders
Gynecomastia 1 (3.3)
Neoplasms benign, malignant and unspecified Dermoid
cyst 1 (3.3)

Postmarketing Experience

The following adverse reactions have been identified during post approval use of Follistim and/or Follistim AQ Cartridge. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Gastrointestinal Disorders

Abdominal distension, abdominal pain, constipation, diarrhea

General Disorders and Administration Site Conditions

Injection site reaction

Reproductive System and Breast Disorders

Breast tenderness, metrorrhagia, ovarian enlargement, vaginal hemorrhage

Skin and Subcutaneous tissue Disorders

Rash

Vascular Disorders

Thromboembolism [see WARNINGS AND PRECAUTIONS]

DRUG INTERACTIONS

No drug-drug interaction studies have been performed.

Read the entire FDA prescribing information for Follistim AQ Cartridge (Follitropin Beta Injection)

SLIDESHOW

Fertility Options: Types, Treatments, and Costs See Slideshow

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

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