What pregnancy category is Humira?

Pregnancy Safety Rating: Category B, caution in nursing.

Is Humira safe to take during pregnancy?

Humira is likely to be safe for use by pregnant women. A study of Humira in pregnant animals didn’t show any risk to the fetus. Clinical studies in humans didn’t show risk to the fetus either. These studies did indicate that the drug crosses the placenta in the greatest amount during the third trimester.

What is Category B medication in pregnancy?

Category B drugs include prenatal vitamins, acetaminophen and several other medications used routinely and safely during pregnancy. If there is a clinical need for a Category B drug, it is considered safe to use it.

Are Biologics safe during pregnancy?

The FDA has classified the antibody biologic drugs infliximab (IFX), adalimumab (ADA) and golimumab (GOL) as category B, meaning that there is no evidence so far of aggravated risks of malformation in pregnant women under these treatments.

Can you take Humira while breastfeeding?

Adalimumab (Humira®; Abbvie, North Chicago, IL) is a monoclonal antibody that acts as a TNF inhibitor. It transfers into breastmilk in small amounts but is not likely absorbed by the infant. Most experts state that adalimumab is likely compatible with breastfeeding.

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Is Humira an immunosuppressant?

Types of immunosuppressants include: Biologics such as adalimumab (Humira®) and infliximab (Remicade®). Calcineurin inhibitors such as tacrolimus (Envarsus XR® or Protopic) and cyclosporine (Gengraf®, Neoral® or Sandimmune®).

What drugs are Category C for pregnancy?

OTC Antacids, Simethicone, and H2-Receptor Selective Antihistamines in Pregnancy

Drug name FDA pregnancy risk classification Drug class
Calcium carbonate (Tums) C Antacid
Simethicone (Mylanta Gas) C Antiflatulent
Cimetidine (Tagamet) B Antihistamine
Ranitidine (Zantac) B Antihistamine

What is a Category C drug when pregnant?

Category C: Either studies in animals have revealed adverse effects on the fetus (teratogenic or embryocidal, or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the fetus.

What are Category D drugs in pregnancy?

Category D:

Drugs in this class may be used in pregnancy if the benefits to the mother outweigh the risk to the fetus (i.e. a life threatening situation or a serious disease for which safer medication cannot be used or are not efficacious). Examples of medications in this class are phenytoin and valproic acid.

Can Humira cause miscarriage?

Does taking adalimumab increase the chance for miscarriage? Miscarriage can occur in any pregnancy. In a survey sent to rheumatologists, the doctors reported no increase miscarriage rates in 417 women exposed to adalimumab or another TNF inhibitor during pregnancy.

Which biologic does not cross the placenta?

Certolizumab pegol does not cross the placenta in large amounts in the second and third trimester. In a different study of 16 women who used certolizumab pegol throughout pregnancy, certolizumab could only be detected in the blood of one infant at birth, and it was at a very low level.

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Is Humira worth the risk?

A black box warning in Humira’s label highlights the risk of serious infections leading to hospitalization or death, including TB, bacterial sepsis, invasive fungal infections and infections due to opportunistic pathogens.

Common Side Effects.

Side Effects Humira (705 patients) Placebo (690 patients)
Rash 12% 6%

Does Humira lower your sperm count?

Adalimumab therapy was associated with a significant decrease in sperm count in a 35-year-old man who had taken the biologic for 3 years as treatment for ankylosing spondylitis, according to a case report presented in the March issue of Annals of the Rheumatic Diseases.

Can RA cause birth defects?

Although some women with RA may have a slight risk of miscarriage or low-birth-weight babies, the vast majority have normal pregnancies without complications. However, many drugs for rheumatoid arthritis — including methotrexate (Otrexup, Rheumatrex, Trexall) and leflunomide (Arava) — can cause birth defects.

Why does Humira cause weight gain?

After your inflammation and pain are controlled with Humira, you may feel better and your appetite may return, leading to weight gain. This typically would happen slowly over time.