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Bonmiraa

Glamvita-Soap-&-Cream
Bonmiraa

Bonmiraa is a Rheumatology product of original adalimubab. A Rheumatology is a biologic medical product highly similar to another already approved biological medicine (the 'reference medicine'). Rheumatologys are approved according to the same standards of pharmaceutical quality, safety and efficacy that apply to all biological medicines. Rheumatologys are officially approved versions of original "innovator" products

What is Adalimumbab

Adalimumab, is a medication used to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, psoriasis, hidradenitis suppurativa, uveitis, and juvenile idiopathic arthritis. Use is generally only recommended in people who have not responded to other treatments. It is used by injection under the skin.

Adalimumab is a disease-modifying antirheumatic drug and monoclonal antibody that works by inactivating tumor necrosis factor-alpha (TNFα). Adalimumab was approved for medical use in the United States in 2002. It is on the World Health Organization's List of Essential Medicines, which lists the safest and most effective medicines needed in a health system

Bonmiraa - Medical Uses

Like other TNF inhibitors, it is an immunosuppressive medication, used to treat autoimmune diseases such as rheumatoid arthritis. Adalimumab is administered by subcutaneous injection. For most indications, the maintenance treatment is an injection every other week.

Rheumatoid Arthritis

Bonmiraa 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. Bonmiraa can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs).

Juvenile Idiopathic Arthritis

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

Psoriatic Arthritis

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

Ankylosing Spondylitis

Bonmiraa is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis.

Plaque Psoriasis

Bonmiraa 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. Bonmiraa should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician

Adult Crohn's Disease

Bonmiraa 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. Bonmiraa 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.

Paediatric Crohn's Disease

Bonmiraa is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in paediatric 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

Bonmiraa 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 Bonmiraa has not been established in patients who have lost response to or were intolerant to TNF blockers [see Clinical Studies

Hidradenitis Suppurativa

Bonmiraa is indicated for the treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older.

Uveitis

Bonmiraa is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adults and paediatric patients 2 years of age and older

Adverse effects

There is strong evidence that adalimumab increases risk of serious infections, such as tuberculosis. It also increases the risk of cancers, including lymphoma and solid malignancies. The risk of cancer is higher with higher doses of adalimumab.

There are rare reports of serious liver injury; rare reports of demyelinating central nervous system disorders; and rare reports of cardiac failure—the U.S. Food and Drug Administration (FDA) issued a black box warning to doctors, which appears in the product labelling of adalimumab and other TNF-inhibiting drugs, instructing them to screen and monitor potential patients more carefully Anaphylaxis or other serious allergic reactions may also occur.

Storage and Stability

Do not use beyond the expiration date on the container. Bonmiraa must be refrigerated at 36°F to 46°F (2°C to 8°C). DO NOT FREEZE. Do not use if frozen even if it has been thawed. Store in original carton until time of administration to protect from light.

If needed, for example when traveling, Bonmiraa 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. Bonmiraa should be discarded if not used within the 14-day period. Record the date when Bonmiraa is first removed from the refrigerator in the spaces provided on the carton and dose tray. Do not store Bonmiraa in extreme heat or cold.

How Bonmiraa Works

Adalimumab binds specifically to TNF-alpha and blocks its interaction with the p55 and p75 cell surface TNF receptors. Adalimumab also lyses surface TNF expressing cells in vitro in the presence of complement. Adalimumab does not bind or inactivate lymphotoxin (TNF-beta). TNF is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Elevated levels of TNF are found in the synovial fluid of patients with RA, JIA, PsA, and AS and play an important role in both the pathologic inflammation and the joint destruction that are hallmarks of these diseases. Increased levels of TNF are also found in psoriasis plaques. In Ps, treatment with Bonmiraa may reduce the epidermal thickness and infiltration of inflammatory cells. The relationship between these pharmacodynamic activities and the mechanism(s) by which Bonmiraa exerts its clinical effects is unknown.

Adalimumab also modulates biological responses that are induced or regulated by TNF, including changes in the levels of adhesion molecules responsible for leukocyte migration (ELAM-1, VCAM-1, and ICAM-1 with an IC50 of 1-2 X 10-10M).

Contraindications

None

IMPORTANT SAFETY INFORMATION

ABOUT Bonmiraa (Adalimumab)

You should discuss the potential benefits and risks of Bonmiraa with your doctor. Bonmiraa is a TNF blocker medicine that can lower the ability of your immune system to fight infections. You should not start taking Bonmiraa if you have any kind of infection unless your doctor says it is okay.

  • Serious infections have happened in people taking Bonmiraa. These serious infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some people have died from these infections. Your doctor should test you for TB before starting Bonmiraa, and check you closely for signs and symptoms of TB during treatment with Bonmiraa, even if your TB test was negative. If your doctor feels you are at risk, you may be treated with medicine for TB.
  • Cancer. For children and adults taking TNF blockers, including Bonmiraa, the chance of getting lymphoma or other cancers may increase. There have been cases of unusual cancers in children, teenagers, and young adults using TNF blockers. Some people have developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death. If using TNF blockers including Bonmiraa, your chance of getting two types of skin cancer (basal cell and squamous cell) may increase. These types are generally not life-threatening if treated; tell your doctor if you have a bump or open sore that doesn’t heal.

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
  • Get a lot of infections or infections that keep coming back
  • Have diabetes
  • Have TB or have been in close contact with someone with TB, or were born in, lived in, or travelled where there is more risk for getting TB
  • Live or have lived in an area (such as the Ohio and Mississippi River valleys) where there is an increased risk for getting certain kinds of fungal infections, such as histoplasmosis, coccidioidomycosis, or blastomycosis. These infections may happen or become more severe if you use Bonmiraa Ask your doctor if you are unsure if you have lived in these areas
  • Have or have had hepatitis B
  • Are scheduled for major surgery
  • Have or have had cancer
  • Have numbness or tingling or a nervous system disease such as multiple sclerosis or Guillain-Barré syndrome
  • Have or had heart failure
  • Have recently received or are scheduled to receive a vaccine. Bonmiraa patients may receive vaccines, except for live vaccines. Children should be brought up to date on all vaccines before starting Bonmiraa
  • Are allergic to rubber, latex, or any Bonmiraa ingredients
  • Are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed
  • Have a baby and you were using Bonmiraa during your pregnancy. Tell your baby’s doctor before your baby receives any vaccines

Also tell your doctor about all the medicines you take. You should not take Bonmiraa with abatacept, anakinra ,etanercept,certolizumab pegol, golimumab. Tell your doctor if you have ever used rituximab, azathioprine or mercaptopurine (6-MP).

Bonmiraa can cause serious side effects, including:

  • Serious infections. These include TB and infections caused by viruses, fungi, or bacteria. Symptoms related to TB include a cough, low-grade fever, weight loss, or loss of body fat and muscle.
  • Hepatitis B infection in carriers of the virus. Symptoms include muscle aches, feeling very tired, dark urine, skin or eyes that look yellow, little or no appetite, vomiting, clay-colored bowel movements, fever, chills, stomach discomfort, and skin rash.
  • Allergic reactions. Symptoms of a serious allergic reaction include hives, trouble breathing, and swelling of your face, eyes, lips, or mouth.
  • Nervous system problems. Signs and symptoms include numbness or tingling, problems with your vision, weakness in your arms or legs, and dizziness.
  • Blood problems (decreased blood cells that help fight infections or stop bleeding). Symptoms include a fever that does not go away, bruising or bleeding very easily, or looking very pale.
  • Heart failure (new or worsening). Symptoms include shortness of breath, swelling of your ankles or feet, and sudden weight gain.
  • Immune reactions including a lupus-like syndrome. Symptoms include chest discomfort or pain that does not go away, shortness of breath, joint pain, or rash on your cheeks or arms that gets worse in the sun.
  • Liver problems. Symptoms include feeling very tired, skin or eyes that look yellow, poor appetite or vomiting, and pain on the right side of your stomach (abdomen). These problems can lead to liver failure and death.
  • Psoriasis (new or worsening). Symptoms include red scaly patches or raised bumps that are filled with pus. Call your doctor or get medical care right away if you develop any of the above symptoms.

Common side effects of Bonmiraa include injection site reactions (pain, redness, rash, swelling, itching, or bruising), upper respiratory infections (sinus infections), headaches, rash, and nausea. These are not all of the possible side effects with Bonmiraa. Tell your doctor if you have any side effect that bothers you or that does not go away.

Remember, tell your doctor right away if you have an infection or symptoms of an infection, including:

  • Fever, sweats, or chills
  • Muscle aches
  • Cough
  • Shortness of breath
  • Blood in phlegm
  • Weight loss
  • Warm, red, or painful skin or sores on your body
  • Diarrhea or stomach pain
  • Burning when you urinate
  • Urinating more often than normal
  • Feeling very tired

Bonmiraa is given by injection under the skin.

This is the most important information to know about Bonmiraa. For more information, talk to your health care provider.

Bonmiraa is a prescription medicine used:

  • To reduce the signs and symptoms of:
    • Moderate to severe rheumatoid arthritis (RA) in adults. Bonmiraa can be used alone, with methotrexate, or with certain other medicines. Bonmiraa may prevent further damage to your bones and joints and may help your ability to perform daily activities.
    • Moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 2 years of age and older. Bonmiraa can be used alone, with methotrexate, or with certain other medicines.
    • Psoriatic arthritis (PsA) in adults. Bonmiraa can be used alone or with certain other medicines. Bonmiraa may prevent further damage to your bones and joints and may help your ability to perform daily activities.
    • Ankylosing spondylitis (AS) in adults.
    • Moderate to severe Crohn's disease (CD) and to achieve and maintain clinical remission in adults who have not responded well to certain other medications. Bonmiraa is also used to reduce signs and symptoms and to achieve clinical remission in these adults who have lost response to or are unable to tolerate infliximab.
    • Moderate to severe Crohn's disease (CD) and to achieve and maintain clinical remission in children 6 years of age and older when certain other treatments have not worked well enough.
    • Moderate to severe hidradenitis suppurativa (HS) in people 12 years and older.
  • In adults, to help get moderate to severe ulcerative colitis (UC) under control (induce remission) and keep it under control (sustain remission) when certain other medicines have not worked well enough. It is not known if Bonmiraa is effective in people who stopped responding to or could not tolerate anti-TNF medicines.
  • To treat moderate to severe chronic plaque psoriasis (Ps) in adults who are ready for systemic therapy or phototherapy, and are under the care of a doctor who will decide if other systemic therapies are less appropriate.
  • To treat non-infectious intermediate (middle part of the eye), posterior (back of the eye), and panuveitis (all parts of the eye) (UV) in adults and children 2 years of age and older.