Adalimumab

About Adalimumab

Adalimumab is a tumor necrosis factor (TNF) inhibitor; MedlinePlus says it works by blocking the action of TNF, a substance in the body that causes inflammation. Humira is labeled for adults with moderately to severely active rheumatoid arthritis, active psoriatic arthritis, active ankylosing spondylitis or moderate to severe chronic plaque psoriasis; moderately to severely active polyarticular juvenile idiopathic arthritis from age 2; moderately to severely active Crohn’s disease (adults and children 6 and older) and ulcerative colitis (adults and children 5 and older); moderate to severe hidradenitis suppurativa from age 12; and non-infectious intermediate, posterior and panuveitis in adults and children 2 and older. Adults with rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis take 40 mg every other week; adults with Crohn’s disease or ulcerative colitis start with 160 mg on day 1 and 80 mg on day 15, then 40 mg every other week; plaque psoriasis and adult uveitis start with 80 mg, then 40 mg every other week. Juvenile arthritis doses are set by weight.

The boxed warning says people taking adalimumab are at increased risk of serious infections that may lead to hospitalization or death, mostly in those also taking immunosuppressants such as methotrexate or corticosteroids. Reported infections include tuberculosis, including reactivation of latent infection; invasive fungal infections such as histoplasmosis; and bacterial, viral and other opportunistic infections, including Legionella and Listeria. Patients are tested for latent tuberculosis before and during treatment, latent infection is treated first, and adalimumab is stopped if a serious infection or sepsis develops. Lymphoma and other malignancies, some fatal, have been reported in children and adolescents taking TNF blockers, and hepatosplenic T-cell lymphoma, a rare and aggressive lymphoma that has been fatal, has occurred mostly in people with Crohn’s disease or ulcerative colitis, most of them adolescent and young adult males, almost all of whom had also received azathioprine or 6-mercaptopurine. Other warnings cover hepatitis B reactivation, allergic reactions, new or worse demyelinating disease and heart failure, low blood counts, and lupus-like syndrome or autoimmune hepatitis. Infections, injection site reactions, headache and rash are the most common side effects.

Available studies do not reliably establish an association between adalimumab and major birth defects, and the label says to weigh risks and benefits before giving live vaccines to a baby exposed in the womb. The needle cover of Humira’s 40 mg/0.8 mL pen and syringe may contain natural rubber latex, and those are its only presentations containing citric acid and sodium citrate. Several biosimilars also come in the higher-concentration 40 mg/0.4 mL form. The FDA has determined some biosimilars interchangeable with specific Humira presentations, beginning with Cyltezo’s prefilled syringes in October 2021; Abrilada, Amjevita, Hadlima and Simlandi are among the others, and the FDA Purple Book lists current designations.

Taking Adalimumab

How to take it

Inject under the skin of the front of the thighs or the stomach, not within 2 inches of the navel and at least 1 inch from the last spot used, on the schedule prescribed. Let it warm to room temperature for 15 to 30 minutes before injecting.

If you miss a dose

Inject the missed dose as soon as you remember, then take the next dose on your regular schedule.

Storage

Keep Humira in the refrigerator at 36 to 46°F in its original carton to protect it from light, and do not freeze it; it may be kept at room temperature up to 77°F for up to 14 days and is thrown away if not used within that time. Biosimilars set their own limits (Simlandi allows up to 30 days, Hadlima 14 days for its pen and syringe), so follow your product’s instructions.

Interactions to know about

Anakinra and abatacept increase the risk of serious infection, and live vaccines are not given during treatment. Tell the prescriber about any infection, tuberculosis, hepatitis B, heart failure or demyelinating disease before starting.

This summarizes the official prescribing information. Your prescriber’s and pharmacist’s instructions, and the leaflet that comes with your medicine, take priority.

Why the cash price for Adalimumab differs from pharmacy to pharmacy

Adalimumab is a refrigerated biologic sold as Humira, as branded biosimilars and as unbranded versions of some biosimilars (named adalimumab with a suffix, such as adalimumab-adaz), so two pharmacies can quote different products. A quote is for one specific product, strength and device.

Substitution depends on interchangeability, not biosimilarity alone. The FDA says an interchangeable biosimilar may be substituted for the original product without consulting the prescriber, subject to state pharmacy laws, and its interchangeability determinations name specific presentations. A biosimilar without that designation needs the prescriber, and a prescription naming one product limits the quote to it.

Ways to pay less for Adalimumab without insurance

• Ask each pharmacy which adalimumab product, strength and device its quote is for.
• Ask the prescriber whether a biosimilar would suit you, and whether the prescription can allow an interchangeable product.
• Ask the maker of the product prescribed whether its patient assistance or savings program applies to someone paying cash; many copay cards require commercial insurance.
• Upload the prescription to Script Unlock so licensed pharmacies can quote their cash price. You pay the pharmacy directly.

Questions to ask your pharmacist about Adalimumab

1. 1.Which adalimumab product is this, and is it interchangeable with what my prescriber wrote?
2. 2.Is my product the 40 mg/0.4 mL or the 40 mg/0.8 mL form?
3. 3.How long can my pen stay at room temperature?
4. 4.Which signs of infection should make me call right away?

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