HUMIRA - Ships From Canada

What is this medication?

HUMIRA/AMJEVITA/HULIO/HADLIMA/SIMLANDI (Adalimumab)
Antirheumatic, Disease Modifying Agent, Gastrointestinal agent, Immunosuppressant, Monoclonal Antibody

Brand Name US: Amjevita
Canadian Equivalent: Amgevita

HUMIRA and biosimilars AMJEVITA, HULIO, HADLIMA, and SIMLANDI are tumor necrosis factor (TNF) blockers that helps reduces the clinical progression and signs and symptoms for rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, and plaque psoriasis when other systemic therapies have not worked or are considered medically less appropriate.

ALERT: WARNING
Patients treated with HUMIRA/AMJEVITA/HULIO/HADLIMA/SIMLANDI (Adalimumab) are at increased risk of developing several serious conditions including bacterial, viral and fungal infections, and tuberculosis.  Serious infections may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants, such as methotrexate or corticosteroids.  Active tuberculosis (TB), including reactivation of latent TB. have occurred and many patients also presented with disseminated or extrapulmonary disease. Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystis have been reported.  Consider empiric antifungal therapy in patients at risk of invasive fungal infections who develop severe systemic illness.  Carefully consider the risks and benefits of treatment with Adalimumab prior to initiating therapy in patients with chronic or recurrent infection.

Lymphoma and other malignancies, some fatal, have been reported in children and adolescents treated with tumor necrosis factor (TNF)–blockers, including adalimumab, HUMIRA.

What is a biosimilar biologic drug?

Manufacturers have found cost-efficient ways to recreate the molecules used in the original or “reference” biologic drug.  Biosimilars are highly “similar” to a reference biological drug despite differing in their chemical composition.  

The FDA approval of biosimilar drugs is based on a totality of evidence which is used by regulators in the approval of reference and biological drugs.  The FDA uses the same approach in evaluating biosimilars to confirm that there are no clinically meaningful differences in safety and efficacy between the reference biologic drug and the biosimilar.  The rigorous standard for authorization means that you can have confidence knowing that the quality, safety, and efficacy of a biosimilar is the same as any other biologic drug.

HUMIRA is a biologic
AMJEVITA is a biosimilar to HUMIRA (Adalimumab)
HULIO is a biosimilar to HUMIRA (Adalimumab)
HADLIMA is a biosimilar to HUMIRA (Adalimumab)
SIMLANDI is a biosimilar to HUMIRA (Adalimumab)

What are the ingredients in this medication?

HUMIRA
Medicinal ingredient:
Adalimumab
Non-medicinal ingredients:
Sodium chloride, monobasic sodium phosphate dihydrate, dibasic sodium phosphate dihydrate, sodium citrate, citric acid monohydrate, mannitol, polysorbate 80, and water for Injection. Sodium hydroxide is added as necessary to adjust pH. Preservative-free.

AMJEVITA
Medicinal ingredient: 
Adalimumab
Non-medicinal ingredients: 
10 mM Glacial acetic acid, 0.10% (w/v) polysorbate 80, sodium hydroxide for pH adjustment and 9.0% (w/v) sucrose, in water for injection. Preservative-free.

HULIO
Medicinal ingredient:
Adalimumab
Non-medicinal ingredients:
Diluted hydrochloric acid, methionine, monosodium glutamate, polysorbate 80, sorbitol, and water for injection (distilled). Preservative-free.

HADLIMA
Medicinal ingredient:
Adalimumab
Non-medicinal ingredients:
Citric acid monohydrate, sodium citrate dihydrate, L-histidine, L-histidine hydrochloride monohydrate, sorbitol, polysorbate 20, and water for injection. Preservative-free.

SIMLANDI
Medicinal ingredient:
Adalimumab
Non-medicinal ingredients:
Sodium chloride, sucrose, polysorbate 80, and water for injection. Preservative-free.

How does this medication work? 

HUMIRA/AMJEVITA/HULIO/HADLIMA/SIMLANDI (Adalimumab) is a recombinant monoclonal antibody that binds to free and transmembrane forms of tumor necrosis factor alpha (TNFα), thereby inhibiting cytokine-driven inflammatory reactions. A reduction in endogenous TNFα activity will reduce proinflammatory mediators (i.e. interleukins), leukocyte migration, neutrophils and eosinophils activation.  

Adalimumab will reduce TNFα levels in the synovial fluid which causes the pathologic pain and joint destruction in immune-mediated arthritis.  Adalimumab decreases signs and symptoms of psoriatic arthritis, rheumatoid arthritis, and ankylosing spondylitis. It inhibits progression of structural damage of rheumatoid and psoriatic arthritis.  Adalimumab reduces signs and symptoms and maintains clinical remission in Crohn disease and ulcerative colitis; reduces epidermal thickness and inflammatory cell infiltration in plaque psoriasis.

How should I take this medication? 

Ankylosing Spondylitis
SQ: Inject 40mg subcutaneously every other week.

Crohn Disease
SQ: Inject 160mg subcutaneously (on day 1 or split and give over 2 consecutive days), then give 80mg 2 weeks later.  Maintenance dose is 40mg every other week beginning on day 29.

Hidradenitis Suppurativa 
SQ: Inject 160mg subcutaneously (on day 1 or split and give over 2 consecutive days), then give 80mg 2 weeks later.  Maintenance dose is 40mg every other week beginning on day 29.

Plaque Psoriasis
SQ: Initial inject 80mg subcutaneously as a single dose then inject 40mg every other week beginning 1 week after the first dose.

Psoriatic Arthritis
SQ: Inject 40mg subcutaneously every other week.

Rheumatoid Arthritis
SQ: Inject 40mg subcutaneously every other week.

Ulcerative Colitis
SQ: Inject 160mg subcutaneously (on day 1 or split and give over 2 consecutive days), then give 80mg 2 weeks later.  Maintenance dose is 40mg every other week beginning on day 29.

Uveitis
SQ: Initial inject 80mg subcutaneously as a single dose then inject 40mg every other week beginning 1 week after the first dose.

How to Take: Inject subcutaneously at separate injection sites in the thigh or lower abdomen (avoid injecting 2 inches within the navel); rotate the 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. Citrate-free formulations may be associated with less pain on injection.

What should I watch for while using this medication? 

Before starting HUMIRA/AMJEVITA/HULIO/HADLIMA/SIMLANDI (Adalimumab), make sure your physician is aware of any allergies or medications you currently take.  Do not start Adalimumab during an active infection.  If an infection develops, monitor carefully, and stop Adalimumab if the infection becomes serious.  Antifungal therapy should be considered if you live or reside in regions of the world where mycoses are endemic.  The incidence of malignancies are higher in those who take Adalimumab.   There is a risk of hepatitis B virus reactivation and as a result HBV carriers should be monitored during and several months after therapy. If reactivation occurs, stop Adalimumab and begin antiviral therapy.  Watch and monitor for cytopenias and pancytopenia. Use Adalimumab with caution in patients with pre-existing or recent onset CNS demyelinating disorders and heart failure.

What size needle does this medication use?

HUMIRA
Prefilled pen: 29-gauge, ½ inch needle
Prefilled syringe: 29-gauge, ½ inch needle

AMJEVITA
Prefilled pen: 27-gauge, ½ inch needle
Prefilled syringe: 29-gauge, ½ inch needle

HULIO
Prefilled pen: 29-gauge, ½ inch needle
Prefilled syringe: 29-gauge, ½ inch needle

HADLIMA
Prefilled pen: 29-gauge, ½ inch needle
Prefilled syringe: 29-gauge, ½ inch needle

What is the difference between a prefilled syringe and an autoinjector?

Both an autoinjector (prefilled pen) device and prefilled syringe are comparable with respect to ease of use, tolerability, and efficacy.  However the addition of an autoinjector to deliver a prefilled syringe can enhance patient safety.

What if I miss a dose?

If you forget to take a dose, inject a dose as soon as you remember. Then, take your next dose at your regular scheduled time. This will put you back on schedule. In case you are not sure when to inject, call your doctor or pharmacist.

How should I store this medication?

HUMIRA should be stored in a refrigerator between 2 to 8°C (36°F to 46°F) in its original container and protected from light until time of administration. Never store in the freezer. Do not use if frozen, even if it has been thawed.

HULIO may be stored at room temperature up to a maximum of 25°C (77°F) for a period of up to 14 days, with protection from light. 

AMJEVITA may be stored at room temperature up to a maximum of 77°F (25°C) for a period of up to 14 days, with protection from light.

HADLIMA can be stored at room temperature (up to 25ºC/77ºF) for a single maximum period of 28 days.

SIMLANDI should be stored in a refrigerator between 2 to 8°C (36°F to 46°F) in its original container and protected from light until time of administration. Never store in the freezer. Do not use if frozen, even if it has been thawed. Do not use beyond the expiration date. Once removed from the refrigerator, SIMLANDI must be used within 14 days or must be discarded.

What are the possible side effects of using this medication?

Headache, skin rash, positive ANA titer, antibody development, infection (children and adolescents, injection site reaction, increased creatine phosphokinase, upper respiratory tract infection, sinusitis.

Note this is not a complete list of side effects for HUMIRA/AMJEVITA/HULIO/HADLIMA/SIMLANDI (Adalimumab), only common ones.