Description

Baricinix (Baricitinib) indicate for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs. Baricinix may use as monotherapy or in combination with Methotrexate.

 

Product Features

Product Name	:	Baricinix
Generic Name	:	Baricitinib
Formulation	:	Tablet
Available Pack Size	:	30’s Pot
Available Strength	:	2 mg
Registrations	:	Export Only

 

Product Description

Baricinix is the first once-daily oral selective JAK1 and JAK2 inhibitor for the treatment of moderate to severe active rheumatoid arthritis (RA) who have not responded well enough to or could not tolerate at least one medicine called a tumor necrosis factor (TNF) antagonist.

Composition

Baricitinix 2 mg Tablet : Each film-coated tablet contains Baricitinib INN 2 mg.

Therapeutic class: Anti-Rheumatic

 

Dosage and Administration

The recommended dose of Baricinix is 4 mg once daily. A dose of 2 mg once daily is appropriate for patients such as those aged ≥ 75 years and may be appropriate for patients with a history of chronic or recurrent infections. A dose of 2 mg once daily may also be considered for patients who have achieved sustained control of disease activity with 4 mg once daily and are eligible for dose tapering.

 

Treatment should not be initiated in patients with an absolute lymphocyte count (ALC) less than 0.5 x 109 cells/L, an absolute neutrophil count (ANC) less than 1 x 109 cells/L, or who have a hemoglobin value less than 8 g/dL. Treatment may be initiated once values have improved above these limits.

 

Renal impairment

The recommended dose is 2 mg once daily in patients with creatinine clearance between 30 and 60 mL/min. Baricinix is not recommended for use in patients with creatinine clearance < 30 mL/min. Hepatic impairment No dose adjustment is required in patients with mild or moderate hepatic impairment. Baricitinib is not recommended for use in patients with severe hepatic impairment. Co-administration with OAT3 inhibitors: The recommended dose is 2 mg once daily in patients taking Organic Anion Transporter 3 (OAT3) inhibitors with a strong inhibition potential, such as probenecid. Pediatric population The safety and efficacy of Baricinix in children and adolescents aged 0 to 18 years have not yet been established. No data are available. Method of administration Baricitinib is to be taken once daily with or without food and may be taken at any time of the day.

 

Important safety information: Serious infections. Baricinix is a medicine that affects your immune system. Baricinix can lower your immune system’s ability to fight infections, which can make you more likely to get infections or make infections worse. Some people have had serious infections while using Baricinix, including tuberculosis (TB) and infections caused by bacteria, fungi, or viruses that can spread throughout the body.

 

Your healthcare provider (HCP) should test you for TB before starting Baricinix and watch closely for signs and symptoms of TB during treatment. You should not start Baricinix if you have any kind of infection unless your HCP tells you it is okay. You may be at higher risk of developing shingles. While taking Baricinix, tell your Doctors right away if you have symptoms of an infection, including: o Fever o Sweating o Chills o Muscle aches o Cough o Shortness of breath o Blood in phlegm o Weight loss o Warm, Red, or Painful skin or Sores o Diarrhea or Stomach pain o Burning with urination or Urinating more often than normal o Feeling very tired ADDITIONAL INFORMATION: Baricinix is available by prescription only.

 

Process of taking Baricitinib

Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using Baricitinib. Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed. You may take Baricitinib 2 mg tablet with or without food.

 

Baricitinib affects your immune system. However, get infections more easily, even serious or fatal infections. Then need frequent medical tests. You must remain under the care of a doctor while you are using Baricitinib for COVID-19. Use Baricitinib for the full prescribed length of time (usually for 14 days or until you leave the hospital, whichever comes first).

 

If I miss a dose

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.

Avoid while taking Baricinix

Do not receive a “live” vaccine while using Baricitinib 2 mg. The vaccine may not work as well and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles).

 

Baricitinib side effects

Stop taking Baricitinib 2 mg and get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor right away if you have signs of infection such as:

• Fever, chills, sweating
• Skin sores
• Tiredness, muscle pain
• Increased urination, pain or burning when you urinate
• Stomach pain, diarrhea, weight loss or
• Cough, shortness of breath, coughing up pink or red mucus.

Further doses may be delayed until your infection clears up.

Also call your doctor at once if you have:

• Symptoms of herpes virus–flu-like symptoms, cold sores around your mouth, numbness, tingling, itching, burning pain, painful skin rash or blisters;
• Signs of a blood clot in the lung–chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;
• A blood clot in your leg–swelling, pain, warmth, or redness in an arm or leg;
• Perforation (a hole or tear) in your stomach or intestines–fever, ongoing stomach pain, change in bowel habits; or
• Puberculosis: fever, cough, night sweats, loss of appetite, weight loss, and feeling very tired.

Common side effects may include:

• Herpes symptoms
• Nausea
• Cold symptoms such as stuffy nose, sneezing, sore throat.

 

Warnings

This medicine affects your immune system. infections more easily, even serious or fatal infections.

Before or during treatment with Baricinix , tell your doctor if you have signs of infection such as fever, chills, aches, tiredness, cough, skin sores, diarrhea, or burning when you urinate.

 

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