Adalimumab-exemptia-40mg

Brand name: Exemptia Active ingredient: Adalimumab Strength: 40mg/0.8ml Mfg: Zydus Cadila Pack: one prefilled glass syringe Category: Anti-inflammatory   drug read more

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Drug profile of Exemptia

Exemptia is pharmacologically classified as an anti-tumor necrosis factor drug.

Exemptia containing an active substance known as Adalimumab which is involved in blockade of TNF this leads to reduce the inflammation produces due to excess production of protein called tumor necrosis factor.

Adalimumab is a monoclonal antibody, to human alpha tumor necrosis factor.

Exemptia is a potent anti-inflammatory agent, which is produced by recombinant DNA technology.

Exemptia is a single use prefilled injection.


Prescribing information of Exemptia

The most important prescribing information of Exemptia is;

Rheumatoid arthritis: Exemptia is majorly indicated for diminishing the manifestation occurs due to rheumatoid arthritis and also prohibits the advancement of structural damage & correcting the physical functions in adolescent patient with moderate to severe RA condition.

In RA condition, patient should be treated with Exemptia as a single agent or concomitant use with methotrexate or any other biological disease modifying anti-rheumatoid drugs.

Juvenile idiopathic arthritis: Exemptia is used for decreasing the manifestation occurs during due to this condition. This is used in pediatric patients with the age of 2 years & older. Exemptia should be used as a single agent or by combining with methotrexate.

Psoriatic arthritis: In this condition, Exemptia should be used as single agent or it should be combined with other non-biological DMARDs. Exemptia is indicated in this condition for diminishing the manifestation and reducing the aggravation of structural damage occurs during this condition.

Ankylosing agent: Exemptia is used for treating the manifestation associated with this condition.

Crohn’s disease: (adults & pediatric): Patient who are previously treated with infliximab , followed the Exemptia therapy for decreasing the manifestation and improving the condition of patients. In pediatric patients, it is applicable only for the age of 6 years or older. This Exemptia therapy should be used in patients who are not responding to corticosteroids or immuno modulators like azathioprine, 6-MP, or methotrexate.

Ulcerative colitis: Exemptia is used to treat the ulcerative condition in the patient fail to response the immuno modulators.

Plaque psoriasis: Exemptia should be used in both moderate & severe psoriasis condition

Hidradenitis suppurativa: Exemptia is primarily indicated for this condition

Uveitis: Exemptia should be used for this condition only in adult patients, treated for non infectious condition.

Mechanism of Exemptia

Exemptia containing Adalimumab is exhibits the anti-inflammatory activity by merging to tumor necrosis factor and leads to cause blockade of interaction with p55 & p75 cell surface of TNF receptors.

In the presence of complement, Adalimumab undergoes cell lysis of surface of TNF expressing cells in vitro.

Tumor necrosis factor is a cytokine which is suitable for both inflammatory & immune response activity.

An increased TNF level is the root cause of various life threatening conditions.

Adalimumab is involved in inhibiting the TNF levels which may exhibits anti-inflammatory actions.

Adalimumab involves as alter the biological responses that are triggers by TNF.

Absorption

The peak serum concentration Cmax values of Adalimumab is 4.7 plus or minus 1.6ng/ml

The peak plasma concentration time of Adalimumab reaches between 131 plus or minus 56 hours.

After administration of 40mg dose of Adalimumab causes the mean bioavailability of Adalimumab, by 64%.

Distribution

The volume of distribution ranges from 4.7 to 6.0L

Metabolism

The metabolism of Adalimumab is occurs by opsonization through reticuloendothelial system.

Excretion

The renal clearance of Adalimumab is 12ml/hr

The terminal half life period is 10 to 20 days

When to take the Exemptia

Exemptia should be administered through subcutaneous route.

Dosage regimens of Exemptia

The recommended dosage of Exemptia is depends up on the condition of the patients;

For rheumatoid arthritis, psoriatic arthritis, & Ankylosing spondylitis:

The prescribed dose of Exemptia is 40mg should be administered as SC for every other week.

In this condition, Exemptia should be used in combination of other drugs like methotrexate, other non biologic DMARDS, glucocorticoid, NSAIDS or analgesics.

In RA condition, for some patients receiving methotrexate has additional uses from elevating the dosing frequency of Exemptia to 40mg as every week.

For juvenile idiopathic arthritis;

Exemptia should be used for this condition in the pediatric patients with age of 2 years or older.

In this condition, Exemptia is combined with MTX, glucocorticoid, NAIDs, or analgesics during the treatment.

Depending on body weight;

10kg to <15kg: 10mg of Exemptia should be used for every other week

15kg to <30kg: 20mg of Exemptia should be used for every other

> Or equal to 30kg: 40mg of Exemptia is used for every other week

Crohn’s disease:

In adults;

The recommended dose of Exemptia is 160mg on day 1 as initial dose.

Then continuance dose is 80mg two weeks later.

After 2 weeks of treatment, then start with 40mg of Exemptia dose for every other week.

During this condition, Exemptia should be combined with corticosteroids or Aminosalicylates.

For pediatric patients;

17kg to <40kg: initial dose is 80mg on day 1 & 40mg of Exemptia for 2 weeks later & maintenance dose is 20mg for every other week.

> or equal to 40kg: initial dose is 160mg on day 1; then 80mg of Exemptia for two weeks later & 40mg of Exemptia should be taken as maintenance dose for every other week.

Ulcerative colitis;

The initial dose of Exemptia is 16mg should be given on day 1.

The continuance dose of Exemptia is 80mg two weeks; then resume with the dose of 40mg for every other week.

Exemptia should be continued by combining with azathioprine & 6-MP.

Plaque psoriasis;

Initial dose of Exemptia is 80mg then continue with the dose of40mg for every other week.

Hidradenitis suppurativa;

Initial dose of Exemptia is 160mg, followed by 80mg two weeks

Administration;

The maintenance dose is 40mg for every other week.

Administration of Exemptia is occurs through subcutaneously.

Before injecting the Exemptia solution, keep the Exemptia prefilled syringe at room temperature for 15 to 30 minutes.

Cap of prefilled syringe should not be removed at room temperature.

Injections sites are thigh or abdomen.

Do not inject the solution when it is hard skin, bruised, red or tender.

Exemptia is a single dose syringe.

Discard the unused portion

Exemptia caused side effects

The most common adverse effects of Exemptia are;

Malignancies

Severe infections

Common side effects;

Rash

Pneumonia

Tuberculosis infections

Auto antibodies

Liver enzymes elevations

Immunogenicity

Respiratory tract infection

Flu syndrome

Nausea

Abdominal pain

Increased cholesterol, lipids, alkaline phosphatase

Bloody urine

Headache

UTI

Injection site pain

Hypertension

Pyrexia

Liver failure

Sarcoidosis

Merkel cell carcinoma

Demyelinating disorders

Interstitial lung disease

Stevens Johnson’s syndrome

Erythema multiforme

Vasculitis

Deep vein thrombosis

Drug- drug interaction

Exemptia combined with methotrexate in RA condition causes diminishing the apparent clearance of Adalimumab.

Exemptia combined with biological products causes increased risk of life threatening infections.

Avoid usage of live vaccines during Exemptia treatment

The production of cytochrome 450 enzymes causes diminishing the elevated levels of cytokines during the inflammation.

Avoid using Exemptia in the patients treated with CYP450 substrates.

Food drug interaction

Avoid consuming raw eggs or uncooked meat & poultry.

Take good hygiene.

Diet should be followed by getting the advice from the medical practitioner.

Possible contraindications

Severe infections produced during or after completion of treatment.

Anaphylactic reactions are produced, if patients are contraindicated to the component present in the Exemptia.

Safety measures

Severe infections;

Exemptia therapy has high exposure of serious infection after conclusion of therapy.

This condition is occurs due to concurrent use of Exemptia with anakinra or abatacept will causes increased exposure of infections.

This combination therapy should not be taken.

Before starting the treatment patient should know the risk benefits of Exemptia;

Patients with some adverse should not be take the Exemptia therapy such as;

Patient with advanced or intermittent infection

Patient with risk of exposure of TB

Patient with opportunistic infection

Patient exposed with invasive fungal infection

Malignancies;

Some malignancies occur during the treatment with Exemptia.

Malignancies like non-melanoma skin cancer, lymphoma & leukemia.

Hypersensitivity reactions;

Some severe anaphylactic reactions like angioneurotic edema is produced during the treatment with Exemptia.

In this condition, the treatment should be discontinued.

Hepatitis B rejuvenation;

Exemptia receiving patients have high risk of exposure of hepatitis B infection after completion of therapy.

To avoid such condition, patient should be monitored by counting the HBsAg & anti-HBc levels.

Hepatic function test should be performed periodically.

Neurological problems;

Therapy with Exemptia leads to causes some neurological problems like demyelinating disease, multiple sclerosis, optic neuritis & peripheral demyelinating disease.

During this adverse, Exemptia treatment should be discontinued.

Concomitant use of anakinra;

Exemptia concurrently used with anakinra, causes severe infections.

Heart failure;

Exemptia treatment causes some cardio vascular disorders, during this adverse condition patient should be caution while receiving the Exemptia.

In severe condition, Exemptia treatment should be discontinued.

Immunization;

Caution should be taken, while vaccinating the infants who are receiving Exemptia therpsy.

Live vaccines should be avoided.

Vaccination to pediatric patient should be completed earlier.

In some exceptional condition, patient may take vaccines, but except live vaccines.

Concomitant use of abatacept;

Co administration of Exemptia with abatacept causes serious infection. Avoid using this combination during treatment.

Pregnancy and lactation

AU TGA pregnancy category of Adalimumab is C

US FDA pregnancy category of Adalimumab has not authorized.

Exemptia uses in pregnancy condition in very cautious manner.

Patient should be counsel about the risk benefits of Exemptia, before starting the treatment with Exemptia

Mostly monoclonal antibodies are transported through placenta during pregnancy period.

Care should be taken while using Exemptia in infants during vaccination

Do not use live vaccines

Breast feeding should not be recommended.

Storage and handling

Exemptia prefilled syringe should be stored in a refrigerator condition with the temperature of 2oC to 8oC.

Do not freeze the solution

Protect the carton from light

During travelling period, Exemptia should be able to store at room temperature up to maximum range of 25oC for a period of 14 days.

Discard the syringe, if should not used within 14 days.

Exemptia syringe should be taking from fridge & kept in room temperature before administration.

Do not keep the Exemptia prefilled syringe at high cold or heat place.

Missed dose

Do not miss the Exemptia dose.

Maintain the regular dosing cycle

In case missed dose occurs, patient must get advice from medical practitioner and follow the instructions.

Exemptia has high chance of getting severe infections.

Over dosage

If patient suffered with over dosage, must be provided with

General supportive treatment

Appropriate management of symptomatic therapy should be performed.

Monitor the manifestation due to over dosage of Exemptia.

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