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BMJ 2015; 350 doi: https://doi.org/10.1136/bmj.h1723 (Published 01 April 2015) Cite this as: BMJ 2015;350:h1723

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Monitoring of quality of life of patient and risk benefit is needed before considering off label prescription

Monoclonal antibodies (mAbs) are established therapies for malignancies, transplant rejection, autoimmune and infectious diseases, as well as a range of new indications. However, a series of adverse effects are listed with their use. Some of them such as immune reactions, acute anaphylaxis, cardiotoxicity, life-threatening cytokine release syndrome, serum sickness are life threatening.

Numerous adverse effects of mAbs are related to their specific targets and include ranges of complaints from patients. More common are Black, tarry stools, bleeding gums, body aches or pain, burning, tingling, numbness, or pain in the hands, arms, feet, or legs, chest pain or discomfort, chills, cloudy urine, convulsions, cough, cracks in the skin, decreased urine output, difficult or labored breathing, dilated neck veins, dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position, ear congestion, extreme fatigue, fever, irregular breathing, irregular heartbeat, lack or loss of strength, lightheadedness, loss of appetite, loss of heat from the body, loss of voice, mood changes, nasal congestion, nervousness, pain, pain, redness, or swelling in the arm or leg, painful or difficult urination, pinpoint red spots on the skin, pounding in the ears, rapid breathing, redness, runny nose, sensation of pins and needles, slow or fast heartbeat, sore throat, weight gain, swollen glands, tightness in the chest.

Some less common side effects are difficulty with swallowing, fainting, severe constipation, severe vomiting, blisters, blurred vision, coma, Gastrointestinal perforations, wound healing complications, hemorrhage, hypertension, proteinuria, CHF, infusion-related reactions, immunogenicity and are common with Avastin (Bevacizumab).

While it requires quite vigorous supervision and strict monitoring in well approved conditions, and in view of the above scenario, it should be carefully evaluated not merely for survival benefits but for the quality of life of patients before off label prescription.

References:
Nature Reviews Drug Discovery 9, 325–338 (1 April 2010)
Preclinical and clinical safety of monoclonal antibodies. Mohammad A. Tabriz, Lorin K. Roskos, Drug Discovery Today. Volume 12, Issues 13–14, July 2007, Pages 540–547

Competing interests: No competing interests

10 April 2015
Neeta Kumar
Scientist
Neeru Gupta, Pratik Kumar
ICMR
ICMR HQRS, New Delhi-29