CinnoRA®


(Adalimumab)

Beyond the symptom control


Description

CinnoRA® (adalimumab) is a recombinant human IgG1 monoclonal antibody specific for human tumor necrosis factor (TNF). Adalimumab was created using phage display technology resulting in an antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions.

CinnoRA® is produced by recombinant DNA technology in a mammalian cell expression system and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons.

CinnoRA® is supplied as a sterile, preservative-free solution of adalimumab for subcutaneous administration.

The drug product is supplied as a 0.8 mL single-use pre-filled syringe in Auto Injector Device. The solution of CinnoRA® is clear and colorless, with a pH of about 5-5.5.

Each 40 mg/0.8 mL prefilled syringe, delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of CinnoRA® contains adalimumab 40 mg, citric acid monohydrate 1.04 mg, dibasic sodium phosphate dihydrate 1.22 mg, mannitol 9.6 mg, monobasic sodium phosphate dihydrate 0.69 mg, polysorbate 80 0.8 mg, sodium chloride 4.93 mg, sodium citrate 0.24 mg and Water for Injection, EP.

Indication and Usage

Rheumatoid Arthritis

CinnoRA® is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. CinnoRA® can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs).

Juvenile Idiopathic Arthritis

CinnoRA® is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. CinnoRA® can be used alone or in combination with methotrexate.

Psoriatic Arthritis

CinnoRA® is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. CinnoRA® can be used alone or in combination with non-biologic DMARDs.

Ankylosing Spondylitis

CinnoRA® is indicated for reducing signs and symptoms in adult patients with active ankylosing Spondylitis.

Adult Crohn’s Disease

CinnoRA® is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy. CinnoRA® is indicated for reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab.

Pediatric Crohn’s Disease

CinnoRA® is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active Crohn’s disease who have had an inadequate response to corticosteroids or immunomodulators such as azathioprine, 6-mercaptopurine, or methotrexate.

Ulcerative Colitis

CinnoRA® is indicated for inducing and sustaining clinical remission in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to immunosuppressants such as corticosteroids, azathioprine or 6-mercaptopurine (6-MP). The effectiveness of CinnoRA® has not been established in patients who have lost response to or were intolerant to TNF blockers.

Plaque Psoriasis

CinnoRA® is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. CinnoRA® should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.

Hidradenitis Suppurativa

CinnoRA® is indicated for the treatment of moderate to severe hidradenitis suppurativa.

Uveitis

CinnoRA® is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients.

FAQs

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The recommended initial dose of CinnoRA® for adult patients with crohn’s disease, ulcerative colitis and hidradenitis suppurativa is 160 mg which can be given as four 40 mg injections on day 1 or split as two 40 mg injections per day over two consecutive days.

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Baseline monitoring:

Monitor latent TB screening prior to initiating, HBV screening prior to initiating.

LFT and CBC with differential prior to initiating, Signs or symptoms of active infection, including tuberculosis.

 

Ongoing monitoring:

Monitor latent TB during therapy (Consider at least a yearly PPD); Periodic CBC with differential; HBV carriers (during and for several months following therapy); LFT*;

*For other two drugs, the decision should be made by physician based on the case.

Signs or symptoms of active infection, including tuberculosis (during, and following therapy);

 

 

Periodic history, physical examination and monitoring for improvement of signs, symptoms, or worsening of heart failure, signs and symptoms of hypersensitivity reaction; symptoms of lupus-like syndrome; signs or symptoms of malignancy (including periodic skin examination) or signs or symptoms of demyelinating disorders (eg, multiple sclerosis, Guillain-Barré syndrome) are recommended while on treatment.

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Tell your doctor about all of your health conditions, including if you:

-Have an infection, are being treated for infection, or have symptoms of an infection

-Are scheduled for major surgery

-Have TB or living in an endemic region or have a contact with a patient with TB.

-Have Hepatitis B or have a history of Hepatitis B

-Have or have had cancer

-A nervous system disease such as multiple sclerosis or Guillain-Barre syndrome

- Have or had heart failure

-Have diabetes

 -Are allergic to any CinnoRA® or any ingredients of it.

-Are pregnant, planning to be pregnant, breastfeeding or planning to breastfeed

-Have recently received or are scheduled to receive e vaccine.

-Know the medicines you take. Keep a list of your medicines with you to show your doctor and pharmacist each time you get a new medicine.

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Always inform your doctor if you are pregnant or planning to become pregnant, breastfeeding or planning to breastfeed before using any medicine. This drug should only be used during pregnancy if the benefit outweighs the risk to the fetus.

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