Humira: application, side effects, dosage, precautions.

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Humira (adalimumab) is a biological drug used in the treatment of rheumatoid arthritis (RA) and several other autoimmune and inflammatory diseases to control symptoms and disease progression. It is a TNF inhibitor (or TNF blocker) that blocks the activity of tumor necrosis factor alpha ( TNFα ) protein. Humira comes in liquid form and is injected at home.

Approved in 2002, Humira became the third TNF inhibitor. Generics for Humira are not available. However, there are several biosimilar products on the market.

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Applications

TNFα generally helps your immune system fight infection, but in excessive amounts it can cause painful inflammation and severe joint damage, which are common consequences of RA, other forms of inflammatory arthritis , and autoimmune diseases. Drugs like Humira have helped many people with these conditions:

  • Ease the pain
  • Improving joint function
  • Delaying the progression of the disease

Humira is a fully humanized monoclonal antibody. Like all biological products, it is made from biological material. "Fully humanized" means it is made from cloned human antibodies (previous TNF inhibitors used combinations of human and rodent DNA).

Humira is approved by the US Food and Drug Administration (FDA) for the treatment of a variety of conditions in adults and children / adolescents.

  • Rheumatoid arthritis: adults with moderate to severe active RA.
  • Ankylosing spondylitis (AS): adults with active AD.
  • Psoriatic arthritis (PsA): adults with active PsA.
  • Juvenile idiopathic arthritis (JIA): Children 2 years of age and older with moderate to severe active polyarticular JIA.
  • Plaque psoriasis (Ps): adults with moderate to severe psoriasis who are candidates for systemic therapy or phototherapy and when other systemic treatments are less medically appropriate.
  • Ulcerative colitis (UC): Adults with moderate to severe UC who have an inadequate response to immunosuppressive drugs.
  • Crohn's disease (CD): adults with moderate to severe CD who have an inadequate response to conventional therapy or who have stopped responding to infliximab.
  • Pediatric Crohn's disease: Children 6 years and older with moderate to severe CD who have an inadequate response to corticosteroids or immunomodulators.
  • Hidradenitis suppurativa (HS): Moderate to severe HS in people 12 years of age or older.
  • Uveitis (UV): intermediate, posterior, and non-infectious panuveitis in adults and children 2 years of age and older.

Not by label

Humira is sometimes used off-label, especially for the adult adolescent illnesses for which the drug is approved. Safety data is available for children ages 2 and up .

Other common off-label uses include:

Humira can also be misused as part of an early aggressive treatment strategy for people with undifferentiated arthritis , a diagnosis often made before full-blown RA is apparent.

Before drinking

TNF inhibitors are generally considered second-line drugs. Healthcare providers usually don't prescribe it until you've tried at least one disease-modifying antirheumatic drug (DMARD) , such as methotrexate or sulfasalazine. If you cannot tolerate DMARD or it is not effective enough to keep your symptoms under control, you may be given Humira in addition to or as a substitute for your current medication.

Talk to your doctor about all the medications, supplements, and vitamins that you are currently taking. While some medications pose a lower risk of interaction when taken with Humira, others may directly contraindicate their use or require careful consideration.

Precautions and contraindications.

Humira can be dangerous for some people. Before you start taking this medicine, tell your doctor if you have:

  • Known allergy to adalimumab or any of the drug's ingredients.
  • Active infection
  • Uncontrolled diabetes or another medical condition that can make you prone to infection.
  • Active hepatitis B or is a carrier
  • Tingling numbness
  • Multiple sclerosis
  • Central nervous system disease
  • Previous heart failure

Animal studies have not linked this drug to fetal harm or birth defects. Statistics of pregnancy and delivery in humans show a slight increase in the association with birth defects and preterm delivery; however, this may be due to disease activity rather than medication.

However, Humira is not recommended during pregnancy and breastfeeding. It crosses the placenta and can interfere with your baby's immune response during the third trimester.

You may need to postpone the launch of Humira if you plan to have surgery or vaccinations in the near future.

Other TNF inhibitors

When choosing a biological TNF inhibitor, your healthcare provider may consider Humira or any of the similar medications on the market, including:

Biosimilars

Biosimilars are what they sound like: drugs designed to work in the same way as the biologics on which they are based. A biosimilar must not have significant differences from its reference medicine, including (and especially) the level of effectiveness.

Humira biosimilars include:

These drugs are cheaper than biologics. But your pharmacist cannot substitute a biological analog for a biological product, even if your doctor consents. A completely new prescription must be written for such a drug.

There are also biosimilars for Enbrel and Remicade. In mid-2020, there was nothing for Simponi and Cimzia.

Dose

Humira is given by subcutaneous injection only once every 14 days. If this is not enough to reduce symptoms, your healthcare provider may increase it up to once a week.

The medicine is available in the form of a disposable pre-filled syringe or disposable syringe pen. Available dosages include 10 milligrams (mg), 20 mg, 40 mg, and 80 mg.

For some conditions, Humira has a short-term starting dose that is different from a long-term maintenance dose. Be sure to follow your doctor's instructions carefully.

Standard dose of Humira for adults
NOTE INTRODUCTION MAINTENANCE
Rheumatoid arthritis Nobody 40 mg / 14 days
Psoriasic arthritis Nobody 40 mg / 14 days
Ankylosing spondyloarthritis Nobody 40 mg / 14 days
Crohn's disease 160 mg; 80 mg every two weeks 40 mg / 14 days
Ulcerative colitis 160 mg; 80 mg every two weeks 40 mg / 14 days
Plaque psoriasis 80 mg; 40 mg every two weeks 40 mg / 14 days
Purulent hydradenitis 160 mg; 80 mg every two weeks; 40 mg two weeks later 40 mg / 7 days
Uveitis 80 mg; 40 mg every two weeks 40 mg / 14 days

Modifications for children

Humira doses for children and adolescents are based on weight. In some cases, the dose remains the same as for adults. In others, it should be lowered.

Be sure to tell your doctor if your child is gaining weight or has a growth spurt between supplements so the dose can be adjusted to your child's new weight.

The indicated doses are recommended by the manufacturer.

Standard dose of Humira for children
NOTE Body mass INTRODUCTORY INFORMATION MAINTENANCE
Juvenile idiopathic arthritis, infantile uveitis It varies Nobody 22-32 pounds
10 mg / 14 days

33-65 pounds
20 mg / 14 days

66 pounds or more
40 mg / 14 days

Crohn's disease 37-87 pounds *

Day 1: 80 mg

Day 15: 40 mg

Day 29: 20 mg

Then repeat every 14 days.

Purulent Hidradenitis in Adolescence. 66-131 lbs * (12 years and older)

Day 1: 80 mg

Day 8: 40 mg

Day 22: 40 mg

Then repeat every 14 days.

* Overweight children can take the adult dose.

How to take and store

Injecting is fairly straightforward as the syringe and pen are pre-filled with the correct dose of Humira.

Your doctor's office should offer you training on how to inject yourself. The medicine must also be accompanied by an information package with instructions for its correct use. Producer AbbVie also offers instructional videos on its website .

Humira needs to keep cool. It will be delivered to you in an insulated container and you should put it in the refrigerator right away (unless you plan to use it right away). Do not freeze this medicine or use it if it has ever been frozen.

Protect the drug from light. Store in its original packaging until ready to use.

On injection days, take the medicine out of the refrigerator and let it warm naturally to room temperature. Don't try to heat it up faster.

If you are traveling or for other reasons you cannot store Humira in the cold, you can store it at room temperature (up to 77 degrees Fahrenheit) for up to two weeks. If it does not cool for more than 14 days or exceeds this temperature, do not use it.

Abbvie recently introduced a citrate-free formula that has the advantage of being less painful. The needle is thinner and less medicine is injected, which can reduce injection discomfort.

Side effects

For the advantages of Humira, as for any medicine, there are potential drawbacks. It is important to know what is normal and what should motivate you to call your doctor.

general

The most common side effects of Humira are mild and include:

  • Mild reactions at the injection site.
  • Rash
  • Headache
  • Nausea
  • Back pain

This should decrease over time. If they persist or become severe, see your doctor.

Severe form

Less often, more serious side effects can occur. You should call your doctor immediately or seek medical attention if you experience:

  • Numbness or tingling
  • Eye sight problems
  • Leg weakness
  • Chest pain
  • Difficulty breathing
  • Sun-sensitive rash
  • New joint pain
  • Signs of infection (eg, fever, chills, sore throat)
  • Unusual bruising or bleeding
  • Pale skin
  • Dizziness
  • Red, scaly patches, or pus-filled bumps on the skin.

An allergic reaction to a drug can be life-threatening and requires immediate emergency treatment. Signs of an allergic reaction can include:

  • Urticaria
  • Itching
  • Throat constriction (difficulty breathing, swallowing)
  • Swelling (swelling) of the face, legs, or feet.

Warnings and interactions

Humira suppresses your immune system. Like all TNF inhibitors, it has two black box warnings (the most serious type of FDA warning):

  • Serious infections: Humira increases the risk of tuberculosis , sepsis , fungi , and other infections.
  • Certain types of cancer: In clinical trials, some patients had higher rates of cancer and lymphoma in 24 months. Some adolescents and young adults have developed a rare type of lymphoma called hepatosplenic T-cell lymphoma while taking TNF inhibitors.

Humira can also worsen the symptoms of nervous system disorders, including demyelinating disorders . A condition called lupus-like syndrome is also associated with the use of this drug.

Drug interactions

Some medicines can cause problems when used together. Due to the increased risk of serious infections, Humira should not be combined with:

You should also avoid live vaccines while taking Humira. Keep in mind that most vaccines are not live vaccines, so you can receive most of the recommended vaccines. Talk to your doctor about which vaccines are safe / unsafe for you to take this medicine.

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