It should be noted that these side effects do not occur in all patients. These are not all the possible side effects of Javirux®. For more information, ask your healthcare provider or pharmacist.
Javirux® may cause serious side effects including:
Low blood cell count (Thrombocytopenia, Anemia, and Neutropenia). Javirux® is associated with decrease in platelets, red blood cells, and neutrophils. Your healthcare provider will monitor complete blood counts before and during treatment. If you develop bleeding, stop Javirux® and call your healthcare provider.
Tell your healthcare provider if you have:
- frequent infections, fever, chills, sore throat or mouth ulcers due to infections.
- spontaneous bleeding or bruising.
- tiredness, fatigue, pale skin.
- any sign of bleeding in the brain, such as sudden altered level of consciousness, persistent headache, numbness, tingling, weakness or paralysis.
- any sign of bleeding in the stomach or intestine, such as passing black or bloodstained stools, or vomiting blood.
- unexpected bruising and/or bleeding, unusual tiredness, shortness of breath during exercise or at rest, unusually pale skin, or frequent infections (these are signs of blood disorders).
Infections. Before starting treatment, your healthcare provider should evaluate you for active and inactive (“latent”) tuberculosis, as per local recommendations.
It is recommended to screen for HBV prior to commencing treatment with Javirux®. If you have chronic HBV infection, you should be treated and monitored.
Tell your healthcare provider if you have:
- fever, chills or other symptoms of infections, painful skin rash with blisters (possible symptoms of shingles (herpes zoster)).
- fever, pain when urinating (possible symptoms of a urinary tract infection).
- muscle pain, skin redness, and/or difficulty breathing (cytomegalovirus infection).
- fast heart rate, fever, confusion and rapid breathing (possible symptoms of sepsis, which is a condition associated with an infection and widespread inflammation).
- yellowing of the skin and eyes, dark brown-colored urine, right-sided stomach pain, fever and feeling nauseous or being sick (symptoms of recurrence of hepatitis B infection)
- confusion or difficulty thinking, loss of balance or difficulty walking, clumsiness, difficulty speaking, decreased strength or weakness on one side of your body, blurred and/or loss of vision. These may be signs of a serious brain infection and your healthcare provider may suggest further testing and follow-up.
- chronic coughing with blood-tinged sputum, fever, night sweats and weight loss (these can be signs of tuberculosis).
Symptom Exacerbation Following Interruption or Discontinuation of Treatment with Javirux®. After discontinuation of treatment, signs and symptoms from myeloproliferative neoplasms are expected to return. Do not to interrupt or discontinue Javirux® therapy without consulting your healthcare provider.
Non-Melanoma Skin Cancer (NMSC). Javirux® may increase your risk of certain non-melanoma skin cancers. Inform your healthcare provider if they have ever had any type of skin cancer or if they observe any new or changing skin lesions.
Lipid Elevations. Javirux® may increase blood cholesterol and triglycerides. Your blood cholesterol and triglycerides levels should be monitored by your healthcare provider.
Major Adverse Cardiovascular Events (MACE). Major adverse cardiovascular events including myocardial infarction, stroke, and life-threatening cardiovascular events, have been reported for another JAK-inhibitor used to treat rheumatoid arthritis, a condition for which Javirux® is not indicated. If you are, especially a current or past smoker or have other cardiovascular risk factors, be alert for the following signs and symptoms of cardiovascular events.
Call your healthcare provider right away if you have any of the following signs and symptoms of a heart problem:
- you experience sudden shortness of breath or difficulty breathing, chest pain or pain in upper back, swelling of the leg or arm, leg pain or tenderness, or redness or discoloration in the leg or arm as these can be signs of blood clots in the veins.
Thrombosis. The development of a blood clot in a deep vein, usually in the leg (venous thrombosis), or a clot in the lung (pulmonary embolism), has been reported for another JAK-inhibitor used to treat rheumatoid arthritis, a condition for which Javirux® is not indicated. Tell your healthcare provider right away if you have any symptoms such as if you experience sudden shortness of breath or difficulty breathing, chest pain or pain in upper back, swelling of the leg or arm, leg pain or tenderness, or redness or discoloration in the leg or arm as these can be signs of blood clots in the veins.
Secondary Malignancies. If you are a current or past smoker and with a known secondary malignancy (other than a successfully treated NMSC), you should be aware that lymphoma and other malignancies (excluding NMSC) have been reported for another JAK-inhibitor used to treat rheumatoid arthritis, a condition for which Javirux® is not indicated. If you notice skin changes, tell your healthcare provider, as certain types of skin cancer (non-melanoma) have been reported.