Humira During Pregnancy

The primary reason individuals take adalimumab aka Humira is for rheumatoid arthritis. As such, it is unlikely to be used during pregnancy. However, there are still a number of younger individuals who experience rheumatoid arthritis and the other conditions for which is it prescribed, which raises the question of whether or not it is safe to use while pregnant.

Humira is an immunosuppressant and can lower the ability of your immune system to fight bacterial, viral, or fungal infections or make an infection worse. Humira has not been studied during pregnancy or breastfeeding. Animal studies revealed no fetal harm or malformations with IV administration of this drug.

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Be sure to talk with your healthcare provider regarding the use of Humira during pregnancy and breastfeeding.

HUMIRA is a prescription medicine used to reduce the signs and symptoms of:

• Moderate to severe rheumatoid arthritis (RA) in adults. HUMIRA can be used alone, with methotrexate, or with certain other medicines. HUMIRA may prevent further damage to your bones and joints and may help your ability to perform daily activities.
• Moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 2 years of age and older. HUMIRA can be used alone, with methotrexate, or with certain other medicines.
• Psoriatic arthritis (PsA) in adults. HUMIRA can be used alone or with certain other medicines. HUMIRA may prevent further damage to your bones and joints and may help your ability to perform daily activities.
• Ankylosing spondylitis (AS) in adults.
• Moderate to severe Crohn’s disease (CD) and to achieve and maintain clinical remission in adults who have not responded well to certain other medications. HUMIRA is also used to reduce signs and symptoms and to achieve clinical remission in these adults who have lost response to or are unable to tolerate infliximab.
• Moderate to severe Crohn’s disease (CD) and to achieve and maintain clinical remission in children 6 years of age and older when certain other treatments have not worked well enough.
• Moderate to severe hidradenitis suppurativa (HS) in people 12 years and older.
• In adults, to help get moderate to severe ulcerative colitis (UC) under control (induce remission) and keep it under control (sustain remission) when certain other medicines have not worked well enough. It is not known if HUMIRA is effective in people who stopped responding to or could not tolerate anti-TNF medicines.
• To treat moderate to severe chronic plaque psoriasis (Ps) in adults who are ready for systemic therapy or phototherapy, and are under the care of a doctor who will decide if other systemic therapies are less appropriate.
• To treat non-infectious intermediate (middle part of the eye), posterior (back of the eye), and panuveitis (all parts of the eye) (UV) in adults and children 2 years of age and older.

Humira and Pregnancy

Therapeutic Effect: Reduces swelling, tenderness, inflammation of joints; prevents or slows progressive destruction of joints in rheumatoid arthritis (RA). Pregnancy Safety Rating: Category B, caution in nursing. Pregnancy Recommendation: Limited Human Data – Probably Compatible

Humira’s Side Effects:

The use of adalimumab during pregnancy carries a variety of possible side effects. It is important to note that any medication can cause side effects. Possible side effects include:

• Frequent (20%): Pruritus, injection site erythema, pain, swelling.

• Occasional (12%-9%): Headache, nausea, sinusitis, rash.

• Rare (7%-5%): Hypertension, abdominal or back pain.

Pregnancy/Lactation Considerations: It is unknown if this medication is distributed in breast milk.

Adalimumab Pregnancy Summaries:

The following summaries are cited directly from the sources of Briggs, Freeman, & Yaffe and the Reprotox Toxicology Center. Briggs, Freeman, & Yaffe: No developmental toxicity attributable to adalimumab has been observed in a limited number of cases, and the animal data suggest low risk. However, limited human pregnancy experience prevents a more complete assessment of embryo-fetal risk.

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Theoretically, tumor necrosis factor-alpha (TNF) antagonists could interfere with implantation and ovulation, but this has not been shown clinically (1). The maternal benefits from treatment with adalimumab appear to far outweigh the unknown embryo-fetal risks (2, 3).

It is not known if the antibody can cross the placenta early in gestation when most adalimumab exposures have occurred. If it is similar to immunoglobulin G (IgG), clinically significant amounts would cross only late in gestation and thus would present no direct risk to the embryo-fetus during early development.

Because of the long elimination half-life, use before conception may result in inadvertent exposure of an unplanned pregnancy. If adalimumab is used in pregnancy for treatment of rheumatoid arthritis, health care professionals are encouraged to call the toll-free number (877-0311-8972) for information about patient enrollment in the Organization of Teratology Information Specialists (OTIS) Rheumatoid Arthritis study and Pregnancy Registry.

Reprotox Toxicology Center: Preclinical studies in mice and monkeys did not show adverse effects of adalimumab or a comparable antibody on embryo development. Adalimumab is an antibody that binds to TNF-alpha and interferes with its interaction with cell surface receptors. This product is marketed as Humira for the treatment of rheumatoid arthritis and Crohn’s disease.

According to information submitted to the FDA, no adverse effects were noted in the offspring of monkeys treated with up to 100 mg/kg each week. This dose is at least 266 times the recommended human dose based on plasma concentrations.

When a comparable antibody to mouse TNF alpha was administered to pregnant mice, there were no adverse effects on fetal survival or morphologic development (8). There were no adverse effects on immune function in the offspring except an inconsistent decrease in splenic cell expansion in females but not males (9). This observation may not be clinically important.

Recommendations

The American Pregnancy Association recommends consulting your obstetric healthcare provider and any prescribing physician before starting or stopping medications.

If you are pregnant and have questions related to medication use during pregnancy, the Reprotox Toxicology Center is the most comprehensive and user-friendly resource on medication use during pregnancy.

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The American Pregnancy Association does not prescribe medication nor do we serve as a consult for medication use during pregnancy. It is imperative that you discuss the use of any medication during pregnancy with your health care provider.

The purpose of this document is to provide you with information to support discussions with your health care provider.

Sources:

Humira Safety Information

Adalimumab Pregnancy and Breastfeeding Warnings: Drugs.com

Hodgson, Barbara and Kizior, Robert, Saunders Nursing Drug Handbook 2015, Elsevier, St. Louis, MO. ISBN: 978-1-4377-2334-2. Briggs, Gerald, Freeman, Roger and Yaffe, Sumner, Drugs in Pregnancy and Lactation, 9th Ed., Wolters Kluwer/Lippincott Williams & Wilkins, Philadelphia, PA. ISBN: 978-1-60831-708-0, 2011.

Physicians’ Desk Reference (PDR), PDR Network, LLC, Montvale, NJ 07645 ISBN: 978-1-56363-780-3

Reproductive Toxicology Center, https://www.reprotox.org, agent #2687

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