Adalimumab

Name: Adalimumab

What is the dosage for adalimumab?

Adalimumab is injected under the skin. The recommended dose for rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis is 40 mg every other week, but some patients may need weekly administration.

Crohn's disease is treated with 160 mg initially, followed by 80 mg two weeks later, then 40 mg every 2 weeks.

Juvenile idiopathic arthritis is treated with 20 or 40 mg every other week and plaque psoriasis is treated with 80 mg followed by 40 mg every other week.

What else should I know about adalimumab?

What preparations of adalimumab are available?

Prefilled glass syringe: 20 mg/0.4 ml and 40 mg/0.8 ml; Prefilled pen: 40 mg/0.8 ml.

How should I keep adalimumab stored?

Adalimumab should be refrigerated at 2-8 C (36-46 F).

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Reviewed on 4/7/2015 References Reference: FDA Prescribing Information

How should I use adalimumab?

Follow the directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended. Use adalimumab regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

The dose schedule for adalimumab is highly variable and depends on the condition you are treating. You may need an injection only every other week. Or you may need up to 4 injections in 1 day for 2 days in a row. Follow your doctor's dosing instructions very carefully.

Do not start using adalimumab if you have any signs of an infection (fever, chills, night sweats, weight loss, body aches, tiredness, cough with mucus, feeling short of breath, skin sores, stomach pain, diarrhea, pain or burning when you urinate). Call your doctor for instructions.

Adalimumab is injected under the skin. You may be shown how to use injections at home. Do not give yourself this medicine if you do not understand how to use the injection and properly dispose of used needles and syringes. Do not inject adalimumab into skin that is bruised, red, tender, or hard.

Each adalimumab prefilled syringe is for one use only. Throw it away after one use, even if there is still medicine left inside. Do not use a prefilled syringe if the medicine if it looks cloudy or has particles in it. Call your pharmacist for new medicine.

Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

Adalimumab can lower blood cells that help your body fight infections and help your blood to clot. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. Your blood may need to be tested often. Serious and sometimes fatal infections may occur during treatment with adalimumab. Contact your doctor right away if you have signs of infection such as: fever, chills, sore throat, or flu symptoms.

If you need surgery, tell the surgeon ahead of time that you are using adalimumab.

If you have ever had hepatitis B, adalimumab can cause this condition to come back or get worse. You will need frequent blood tests to check your liver function during treatment and for several months after you stop using this medicine.

Store in a refrigerator. If you travel with a prefilled syringe, keep it in a small cooler with an ice pack and protect it from light. Do not remove the prefilled syringe from the refrigerator or cooler until you are ready to give yourself an injection.

Do not freeze adalimumab, and throw away the medicine if it has become frozen.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Introduction

Biologic response modifier and disease-modifying antirheumatic drug (DMARD); a recombinant DNA-derived human immunoglobulin G1 (IgG1) monoclonal antibody specific for human tumor necrosis factor (TNF; TNF-α).1

Index Terms

  • Adalimumab-adbm
  • Adalimumab-atto
  • Amjevita
  • Antitumor Necrosis Factor Alpha (Human)
  • Cyltezo
  • D2E7
  • Human Antitumor Necrosis Factor Alpha

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Pen-injector Kit, Subcutaneous [preservative free]:

Humira Pen: 40 mg/0.8 mL (1 ea) [contains polysorbate 80]

Humira Pen-Crohns Starter: 40 mg/0.8 mL (1 ea) [contains polysorbate 80]

Humira Pen-Psoriasis Starter: 40 mg/0.8 mL (1 ea) [contains polysorbate 80]

Prefilled Syringe Kit, Subcutaneous [preservative free]:

Humira: 10 mg/0.2 mL (1 ea); 20 mg/0.4 mL (1 ea); 40 mg/0.8 mL (1 ea) [contains polysorbate 80]

Humira Pediatric Crohns Start: 40 mg/0.8 mL (1 ea) [contains polysorbate 80]

Dosing Geriatric

Refer to adult dosing.

Dosing Renal Impairment

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Administration

For SubQ injection at separate sites in the thigh or lower abdomen (avoiding areas within 2 inches of navel); rotate injection sites. May leave at room temperature for ~15 to 30 minutes prior to use; do not remove cap or cover while allowing product to reach room temperature. Do not use if solution is discolored or contains particulate matter. Do not administer to skin which is red, tender, bruised, hard, or that has scars, stretch marks, or psoriasis plaques. Needle cap of the prefilled syringe or needle cover for the adalimumab pen may contain latex. Prefilled pens and syringes are available for use by patients and the full amount of the syringe should be injected (self-administration); the vial is intended for institutional use only. Vials do not contain a preservative; discard unused portion.

In Summary

Commonly reported side effects of adalimumab include: upper respiratory tract infection, headache, injection site reaction, skin rash, antibody development, sinusitis, and pain at injection site. Other side effects include: urinary tract infection, abdominal pain, and flu-like symptoms. See below for a comprehensive list of adverse effects.

Usual Adult Dose for Hidradenitis Suppurativa

-Initial dose: 160 mg subcutaneously (given in one day or split over 2 consecutive days), followed by 80 mg subcutaneously 2 weeks later (Day 15)
-Maintenance dose: 40 mg subcutaneously each week beginning on Day 29

Comments:
-Antibiotics may be continued during treatment if necessary.
-The patient should use a topical antiseptic wash on their HS lesions on a daily basis during treatment.

Use: For the treatment of active moderate to severe hidradenitis suppurativa (HS) (acne inversa) in adult patients with an inadequate response to conventional systemic HS therapy

Administrative Information

LactMed Record Number

513

Last Revision Date

20170411

Disclaimer

Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.

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