Warnings for special population
This medicine is not recommended for use in pregnant women unless absolutely necessary. Your doctor will determine the best course of treatment after assessing the condition and evaluating the risks and benefits associated with the use of this medicine.
This medicine is not recommended for use in breastfeeding women unless absolutely necessary. All the risks and benefits should be discussed with the doctor before using this medicine. Your doctor may advise you to discontinue the drug or to discontinue breastfeeding based on your clinical condition.
Adalimumab may interact with many other medicines and their interaction may cause severe adverse effects. Hence, it is advised that you inform the doctor about all your current medicines including any herbs and supplements before beginning treatment with this medicine.
Use of this medicine may affect the immune system, making you susceptible to opportunistic infections from a wide variety of pathogens. Use of this medicine is not recommended if you have an active infection. If a serious infection develops, consult your doctor immediately and discontinue the use of this medicine based on the doctor's advice.
Use of this medicine may cause a malignancy or reactivation of a previously treated malignancy. Hence, it should be used with caution and frequent clinical monitoring should be performed, especially for children, adolescents, and young adults. If a malignancy develops, appropriate dose adjustments or replacement with a suitable alternative may be necessary based on the clinical condition.
Serious allergic reactions
Use of this medicine may cause serious and life-threatening allergic reactions in some people. Discontinue the use of this medicine immediately if any allergic reactions occur.
Hepatitis B virus reactivation
Use of this medicine may increase the risk of reactivation of hepatitis b virus in patients who are chronic carriers. Close clinical monitoring is advised, if the patient is identified as a carrier of the virus, during treatment as well as for several months after the use of this medicine. If the hepatitis B infection is reactivated during treatment, the treatment should be discontinued and appropriate antiviral therapy should be initiated.
Use of this medicine may cause neurological problems and exacerbate the symptoms of nervous system disorders. This medicine should be used with caution in patients with a preexisting nervous system disorder like multiple sclerosis, optic neuritis, Guillain-Barre syndrome, etc. Close monitoring of clinical condition, appropriate corrective measures, dose adjustments, or replacement with a suitable alternative may be necessary in some cases based on the clinical condition.
Use of this medicine may cause blood cell component disorders. Hence, close monitoring of hematological function is advised during treatment with this medicine. Therapy should be stopped if any serious blood cell component abnormality is identified.
Use of this medicine has been associated with worsening of congestive heart failure as well as the new onset of heart failure in some rare cases. Hence, appropriate clinical monitoring is advised during treatment with this medicine. Replacement with a suitable alternative may be necessary in some cases based on the clinical condition.
Use of this medicine may result in the formation of autoantibodies and may cause a lupus-like syndrome. Treatment with this medicine should be discontinued immediately in such cases.
Use of live vaccines should be avoided while the patient is being treated with this medicine. Special precaution is advised for pediatric patients.
Driving or Operating machinery
Use of this medicine may cause blurred vision or dizziness in some patients. It is advised that you do not perform any activities such as driving a vehicle or operating machinery if you experience any of these symptoms during treatment with this medicine.