Humira (Adalimumab): Transforming Lives by Managing Autoimmune Disorders

Humira is an injectable prescription medication, also known by its generic name adalimumab. It is a monoclonal antibody that is typically used to treat various autoimmune diseases. Autoimmune disease is a type of disorder in which your body’s immune system mistakenly attacks healthy cells, tissues, and organs, which results in inflammation and other painful symptoms.

 

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Humira belongs to the class of drugs called tumor necrosis factor (TNF) blockers that work to block the activity of TNF — a protein that causes inflammation in the body. 

Humira was first approved by the FDA in 2002 for the treatment of rheumatoid arthritis (RA). After its first approval, it has now been approved to treat various other autoimmune diseases since 2005. 

What Is Humira Used To Treat?

FDA has approved Humira for the following autoimmune conditions in adults and children: 

• Rheumatoid arthritis (a disease causing joint inflammation)

• Psoriatic arthritis (joint inflammation in addition to red, scaly skin patches)

• Juvenile idiopathic arthritis (a condition characterized by inflammation in one or more joints)

• Ankylosing spondylitis (a disease that causes inflammation in the joints and spine’s ligaments)

• Crohn’s disease (a disease that causes gut inflammation) 

• Ulcerative colitis (a disease that causes inflammation and ulcers in the gut lining)

• Plaque psoriasis (a skin disease that causes red and scaly patches on the skin)

• Hidradenitis suppurativa (a chronic skin condition characterized by lumps, scarring, and pus on the skin)

• Uveitis (inflammation in the eye)

 

How Does Humira Work?

Humira contains an active drug called adalimumab, a monoclonal antibody designed to attach to a TNF protein. TNF proteins cause inflammation and are found at high levels in patients suffering from the aforementioned autoimmune diseases. 

Since Humira is a TNF blocker, it works to block the activity of TNF by attaching to it, thereby reducing the inflammation and other signs and symptoms caused by these diseases. 

 

Dosage Form and Strength

Humira is available in injectable form with the following strengths. It is available in three forms:

Single-dose prefilled glass syringe with the strength of:

• 80 mg/0.8 ml
• 40 mg/0.8 ml or 0.4 ml
• 20 mg/0.4 ml or 0.2 ml
• 10 mg/0.2 ml or 0.1 ml

Single-dose prefilled pen with the strength of: 

• 80 mg/0.8 ml
• 40 mg/0.8 ml or 0.4 ml

Single-dose vial containing 40 mg/0.8 ml of Humira. 

 

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Dosing Information

The dose of Humira depends on the condition being treated, the patient’s age (adult or pediatric), body weight, and response to treatment.

Dose for Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis

The recommended dosage of Humira for adult patients with moderate to severely active rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis is 40 mg every other week. 

Dose for Juvenile Idiopathic Arthritis (JIA) or Pediatric Uveitis

The following are the recommended doses of Humira for children 2 years of age or older based on their body weight:

• Children whose weight is 10 kg to < 15 kg: 10 mg every other week
• Children whose weight is 15 kg to < 30 kg: 20 mg every other week
• Children whose weight is 30 kg and greater: 40 mg every other week

Dose for Crohn’s Disease

For adults:

The initial recommended dose of Humira for adults with Crohn’s disease is 160 mg for Day 1. The dose of 160 mg can be taken on one day (two 80 mg injections) or can be divided into two doses (one 80 mg injection for 2 consecutive days).

• Following that, you’ll receive a dose of 80 mg after 2 weeks (on day 15).  
• After 2 weeks (on day 29), you’ll receive a maintenance dose of 40 mg every other week. 

For pediatric patients:

The recommended dose of Humira for pediatric patients (children 6 years of age and older) who have Crohn’s disease is as follows;

• Pediatrics weighing 17 kg to < 40 kg: 80 mg on day 1, followed by a dose of 40 mg on day 15. After 2 weeks (on day 29), begin with a maintenance dose of 20 mg every other week. 
• Pediatrics weighing 40 kg or greater: 160 mg on day 1, followed by a dose of 80 mg on day 15 (2 weeks after the initial dose). After 2 weeks (on day 29), pediatric patients receive a maintenance dose of 40 mg every other week. 

Dose for Ulcerative Colitis

For adults:

The recommended dose of Humira for adult patients with ulcerative colitis is 160 mg for Day 1. The dose of 160 mg can be taken in one day (two 80 mg injections) or can be divided into two doses (one 80 mg injection for 2 consecutive days). 

• Following that, you’ll receive a dose of 80 mg on Day 15 (after two weeks of the initial dose).  
• After 2 weeks (on Day 29), continue with a maintenance dose of 40 mg every other week. 

For pediatric patients:

The recommended dose of Humira for pediatric patients (children 5 years of age and older) with ulcerative colitis is as follows:

• Pediatrics weighing 20 kg to < 40 kg: 80 mg on the first week (day 1), followed by a dose of 40 mg on day 8 (2nd week) and a dose of 40 mg on day 15 (3rd week).

On week 4 (Day 29), patients will receive a maintenance dose of 40 mg every other week or 20 mg every week, depending on the prescriber’s instructions.  

• Pediatrics weighing 40 kg or greater: 160 mg on day 1 (either a single dose or split over 2 consecutive days), followed by a dose of 80 mg on day 8 (2nd week) and a dose of 80 mg on day 15 (3rd week). On week 4 (Day 29), patients will receive a maintenance dose of 80 mg every other week or 40 mg every week, depending on the prescriber’s treatment plan.

Dose for Hidradenitis Suppurativa

For adults: 

The Humira dosage for adult patients with hidradenitis suppurativa is 160 mg for Day 1. The dose of 160 mg can be taken in one day (two 80 mg injections) or can be divided into two doses (one 80 mg injection for 2 consecutive days). 

• Following that, patients will receive a dose of 80 mg after 2 weeks (on Day 15).  
• After 2 weeks (on Day 29), begin with a maintenance dose of 40 mg weekly or 80 mg every other week. 

For pediatric patients:

The dosage for pediatric patients (children 12 years of age and older) is as follows;

• Pediatrics weighing 30 kg to < 60 kg: 80 mg on day 1, followed by a subsequent dose of 40 mg every other week. 
• Pediatrics weighing 60 kg or greater: 160 mg on day 1, followed by a dose of 80 mg after 2 weeks (Day 15). After 2 weeks (Day 29), patients will receive a maintenance dose of 40 mg weekly or 80 mg every other week. 

Dose for Plaque Psoriasis or Adult Uveitis

The initial dose of Humira for adult patients with plaque psoriasis or adult uveitis is 80 mg, followed by 40 mg every other week. 

In some cases, your doctor may adjust the dose based on your individual response to treatment and any side effects you may experience. It is also important to keep in mind that the information provided here is a general guide and may not apply to everyone.

How Is Humira Given?

Humira is typically given subcutaneously (medication injected under the skin) either by the healthcare provider or caregiver every 2 weeks. 

 

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Is Humira a Form of Chemotherapy?

No, Humira is a biological therapy used to treat inflammatory conditions. 

 

Possible Side Effects of Humira

Like all medications, Humira can cause side effects. Some common side effects include:

• Headache
• Reactions at the injection site (redness, itchiness, or pain)
• Upper respiratory infection
• Rash

In rare cases, more serious side effects such as lymphoma, serious infections (tuberculosis), new or worsening heart failure, and reactions involving the liver or nervous system can occur.

 

Precautions

You should consult your healthcare provider if you have certain medical conditions. Humira may not be suitable for you in the following cases: 

• If you are pregnant or intend to become pregnant. Avoid taking Humira since the impact of Humira on the fetus has not been studied yet.
• If you are breastfeeding or planning to breastfeed. Since the data on Humira secretion in human breast milk is limited, breastfeeding is not recommended during Humira intake. 
• If you have an allergy to any component of Humira.
• If you have lived in an area of the country where fungal infections such as histoplasmosis, coccidioidomycosis, or blastomycosis are more common, and you are at risk of infection.
• If you have a history of infection coming back or have ever had tuberculosis (TB) or hepatitis B.
• If you have a history of cancer or heart failure.
• If you are taking certain biologic medicines, multivitamins, herbal supplements, or over-the-counter medicines.
• If you are scheduled for surgery or a live vaccination.

 

Humira Cost 

Humira is a relatively expensive medication and may not be covered by all insurance plans. The estimated cost for subcutaneous injection may vary depending upon the strength and your prescription coverage.

• Humira subcutaneous kit (40mg/0.4ml) is about $7,299 for a supply of two kits.
• Humira subcutaneous kit (40mg/0.8ml) is about $7,299 for a supply of two kits.
• Humira subcutaneous kit (80mg/0.8ml) is about $14,588 for a supply of two kits.

 

REFERENCES:

1. US Food and Drug Administration. Humira prescribing information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125057s417lbl.pdf
2. HUMIRA® (adalimumab) | A Biologic Treatment Option. (n.d.). https://www.humira.com/
3. HUMIRA® (adalimumab) Dosing Information for Healthcare professionals. (2021, December 12). HUMIRA for Healthcare Professionals. https://www.humirapro.com/dosing#puc-anchor
4. European Medicines Agency. Humira prescribing information. https://www.ema.europa.eu/en/documents/product-information/humira-epar-product-information_en.pdf