Renflexis

Renflexis is a prescription medication used to relieve the symptoms of certain autoimmune disorders (conditions in which the immune system attacks healthy parts of the body and causes pain, swelling, and damage) including rheumatoid and psoriatic arthritis, ulcerative colitis, Crohn's disease, ankylosing spondylitis, and plaque psoriasis.Renflexis belongs to a group of drugs called called tumor necrosis factor-alpha (TNF-alpha) inhibitors. They work by blocking the action of TNF-alpha, a substance in the body that causes inflammation.

This medication comes in an injectable form that is given directly into a vein (IV) by a healthcare provider. It is infused over a period of 2 hours, typically at 0, 2, and 6 weeks, followed by another infusion in 6 to 8 weeks, depending on treated condition.

Common side effects include respiratory infections, coughing, stomach pain and headache.

Renflexis is a prescription medication used to relieve the symptoms of certain autoimmune disorders (conditions in which the immune system attacks healthy parts of the body and causes pain, swelling, and damage) including:

• Moderate to severe rheumatoid arthritis along with methotrexate in adults.
• Crohn's disease (a condition in which the body attacks the lining of the digestive tract, causing pain, diarrhea, weight loss, and fever) in adults and children 6 years of age or older that has not improved when treated with other medications. 
• Ankylosing spondylitis (a condition in which the body attacks the joints of the spine and other areas causing pain and joint damage) in adults.
• Plaque psoriasis (a skin disease in which red, scaly patches form on some areas of the body) in adults.
• Psoriatic arthritis (a skin disease accompanied by joint pain) in adults.
• Ulcerative colitis (condition that causes swelling and sores in the lining of the large intestine) in adults that has not improved when treated with other medications. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Renflexis. See the “Renflexis Precautions” section.

Common side effects of Renflexis include the following:

• stomach pain
• headache
• upper respiratory infections like sinusitis (inflammation of cavities aroumd your nasal passages) and pharyngitis (swelling in the back of the throat)
• infusion-related reactions such as tenderness, warmths or redness

This is not a complete list of Renflexis side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effects that bother you or that do not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• anakinra (Kineret). Co-administration of Renflexis and anakinra (Kineret) may result in increased risk of serious infections.
• tocilizumab (Actemra). Co-administration of Renflexis and tocilizumab (Actemra) may result in increased immunosuppression and infection.
• other biological therapeutics such as adalimumabe (Humira), infliximab (Remicade), or etanercept (Enbrel).
• methotrexate (Rheumatrex). Co-administration of Renflexis and methotrexate may increase Renflexis concentrations.
• medications that use the enzyme CYP3A4 such as budesonide (Entocort), cyclosporine (Neoral, Gengraf, Sandimmune), darifenacin (Enablex), dihydroergotamine (Migranal), fentanyl (Abstral, Fentora, Onsolis, Actiq), pimozide (Orap), quinidine (Cardioquin, Duraquin, Quinact), sirolimus (Rapamune), tacrolimus (Prograf), terfenadine (Seldane), fluticasone (Flovent HFA, Flonase), eletriptan (Relpax), lovastatin (Mevacor), quetiapine (Seroquel), sildenafil (Viagra, Revatio), and simvastatin (Zocor).
• live vaccines. It is recommended that live vaccines not be given when on Renflexis. It is also recommended that live vaccines not be given to infants exposed to infliximab products in the womb, for at least 6 months after birth.
• It is recommended that anti-infective agents not be given concurrently with Renflexis.

This is not a complete list of Renflexis drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Renflexis including the following:

• Serious infections such as TB, viral, fungal, or bacterial infections. Tell your healthcare provider right away if you have some or all of the following symptoms of
  • a fever 
  • feel very tired
  • have a cough 
  • have flu-like symptoms 
  • warm, red, or painful skin

• Increased risk of cancer. The incidence of malignancies including lymphoma is greater in patients treated with Renflexis.
• Hepatitis B virus (HBV) reactivation. Your doctor should do a blood test for hepatitis B virus before you start treatment with Renflexis and occasionally while you are being treated.
• Liver injury. Rare severe liver reactions, some fatal or necessitating liver transplantation, have occurred in patients receiving Renflexis. Tell your doctor if you have
  • jaundice (skin and eyes turning yellow) 
  • dark brown-colored urine 
  • pain on the right side of your stomach area (right-sided abdominal pain) 
  • fever 
  • extreme tiredness (severe fatigue)
• Heart failure. New onset or worsening symptoms of heart failure may occur.
• Hypersensitivity. Serious infusion reactions including anaphylaxis or serum sickness-like reactions may occur. Tell your doctor or get medical help right away if you get any of these symptoms during or after an infusion this medication:
  • hives (red itchy welts) or rash
  • itching
  • swelling of your lips, tongue, throat or face
  • sudden cough
  • shortness of breath, difficulty breathing, or wheezing
  • weakness
  • dizziness or feel faint
  • palpitations (feel like your heart is racing or fluttering)
  • chest pain
• Blood problems. Your body may not make enough of the blood cells that help fight infections or help stop bleeding. Tell your doctor if you
  • have a fever that does not go away 
  • bruise or bleed very easily
  • look very pale
• Nervous system disorders. Tell your doctor if you have
  • changes in your vision 
  • weakness in your arms or legs
  • numbness or tingling in any part of your body 
  • seizures
• Lupus-like Syndrome (an inflammatory disease). Tell your doctor if develop any of the following symptoms
  • chest discomfort or pain that does not go away 
  • shortness of breath
  • joint pain 
  • rash on the cheeks or arms that gets worse in the sun
• New psoriasis or worsening of psoriasis. Tell your doctor if you develop red scaly patches or raised bumps on the skin that are filled with pus.
• Infusion reactions can happen up to 2 hours after your infusion with Renflexis. Symptoms of infusion reactions may include
  • fever 
  • chills
  • chest pain 
  • low blood pressure or high blood pressure
  • shortness of breath 
  • rash 
  • itching

The following side effects happened more in children: anemia (low red blood cells), leukopenia (low white blood cells), flushing (redness or blushing), viral infections, neutropenia (low neutrophils, the white blood cells that fight infection), bone fracture, bacterial infection and allergic reactions of the breathing tract.

Do not take Renflexis if you:

• are allergic to Renflexis or to any of its ingredients
• have heart failure, unless your doctor has examined you and decided that you are able to take Renflexis

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Renflexis, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Renflexis, tell your doctor about all of your medical conditions. Especially tell your doctor if you

• are allergic to Renflexis or to any of its ingredients
• have an infection
• have or have had any type of cancer
• have liver problems
• have had phototherapy
• have heart failure or other heart conditions
• have COPD (Chronic Obstructive Pulmonary Disease), a specific type of lung disease
• have recently received or are scheduled to receive a vaccine
• have or have had a condition that affects your nervous system such as
  • multiple sclerosis, or Guillain-Barré syndrome
  • if you experience any numbness or tingling 
  • if you have had a seizure
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

No studies have been done in animals, and no well-controlled studies have been done in pregnant women. It is not known if Renflexis will harm your unborn baby. Renflexis should be given to a pregnant woman only if clearly needed.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Renflexis crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Renflexis.

• You will be given Renflexis through a needle placed in a vein (IV or intravenous infusion) in your arm.
• Your doctor may decide to give you medicine before starting the Renflexis infusion to prevent or lessen side effects.
• Only a healthcare professional should prepare the medicine and administer it to you.
• Renflexis will be given to you over a period of about 2 hours.
• If you have side effects from Renflexis, the infusion may need to be adjusted or stopped. In addition, your healthcare professional may decide to treat your symptoms.
• A healthcare professional will monitor you during the Renflexis infusion and for a period of time afterward for side effects. Your doctor may do certain tests while you are taking Renflexis to monitor you for side effects and to see how well you respond to the treatment. 

Take this medication exactly as prescribed by your doctor.

The dose your doctor recommends may be based on the following:

• the condition being treated
• how you respond to this medication
• your weight

Renflexis should be administered by infusion directly into a vein over a period of not less than 2 hours.

• The recommended dose of Renflexis for the treatment of Crohn's disease is 5 mg/kg at 0, 2, and 6 weeks, then every 8 weeks. Some adult patients who initially respond to treatment may benefit from increasing the dose to 10 mg/kg if they later lose their response.
• The recommended dose of Renflexis for the treatment of pediatric Crohn's disease is 5 mg/kg at 0, 2, and 6 weeks, then every 8 weeks.
• The recommended dose of Renflexis for the treatment of ulcerative colitis is 5 mg/kg at 0, 2, and 6 weeks, then every 8 weeks.
• The recommended dose of Renflexis for the treatment of rheumatoid arthritis is 3 mg/kg at 0, 2, and 6 weeks, then every 8 weeks. Renflexis should be used in conjunction with methotrexate in the treatment of rheumatoid arthritis. Some patients may benefit from increasing the dose up to 10 mg/kg or treating as often as every 4 weeks.
• The recommended dose of Renflexis for the treatment of ankylosing spondylitis is 5 mg/kg at 0, 2, and 6 weeks, then every 6 weeks.
• The recommended dose of Renflexis for the treatment of psoriatic arthritis and plaque psoriasis is 5 mg/kg at 0, 2, and 6 weeks, then every 8 weeks.
• The recommended dose of Renflexis for plaque psoriasis is 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.

If you take too much Renflexis, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Renflexis is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Renflexis must be refrigerated at 2ºC to 8ºC (36ºF to 46ºF). Do not use Renflexis beyond the expiration date located on the carton and the vial. This product contains no preservative.

Warning: serious infections and malignancy 

Serious infections

Renflexis may decrease your ability to fight infection and increase the risk that you will get a serious infection, including severe viral, bacterial, or fungal infections that may spread throughout the body.

Renflexis should be discontinued if a patient develops a serious infection or sepsis. 

Reported infections include:

• Active tuberculosis, including reactivation of latent (not active) tuberculosis. Tell your doctor if you have or have ever had TB, if you have lived in or visited a place where TB is common, or if you have been around someone who has TB. If you have any of the following symptoms of TB, or if you develop any of these symptoms during your treatment: cough, weight loss, loss of muscle tone fever, or night sweats. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with Renflexis, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.
• Fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated (spread), rather than localized, disease. Patients who are at risk for fungal infections should be treated beforehand.
• Bacterial, viral and other infections due to opportunistic pathogens, including Legionella and Listeria.
• Call your doctor immediately if you have any of the symptoms of hepatitis B or if you develop any of these symptoms during or after your treatment: excessive tiredness, yellowing of the skin or eyes, loss of appetite, nausea or vomiting, muscle aches, dark urine, clay-colored bowel movements, fever, chills, stomach pain, or rash.

The risks and benefits of treatment with Renflexis should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection.

Malignancy (cancer)

Some children, teenagers, and young adults who received Renflexis or similar medications developed severe or life-threatening cancers including lymphoma (cancer that begins in the cells that fight infection). Some teenage and young adult males who took Renflexis or similar medications developed hepatosplenic T-cell lymphoma (HSTCL), a very serious form of cancer that often causes death within a short period of time. Tell your child's doctor if your child has ever had any type of cancer. If your child develops any of these symptoms during his treatment, call his doctor immediately: unexplained weight loss; swollen glands in the neck, underarms, or groin; or easy bruising or bleeding.