Ipilimumab - Dosage | Pregnancy | Effects
Ipilimumab is an anti-CTLA-4 human monoclonal antibody used for the treatment of the advanced or metastatic melanoma. CTLA-4 or Cytotoxic T-lymphocyte-associated molecule-4 binds to the CD80 receptors on dendritic cells (which have important role in immune system) and suppresses the activation of T lymphocytes. Suppression of T lymphocyte activation enable cancer to progress. Ipilimumab blocks this pathway and stops cancer progression.
Warnings and precautions
According to the FDA, following severe reactions may occur while on Ipilimumab therapy:
- Immune-mediated enterocolitis. FDA recommends monitoring of patients for signs and symptoms of enterocolitis (e.g. bloody stools, diarrhea, stomachache and fever). If any of these signs occurs, you should inform your doctor about it. This adverse effect may lead to the fatal outcome. One study which involved 511 patients on Ipilimumab therapy reported 34 patients who developed this adverse effects, from which four patients died due to the complications.
- Immune-mediated hepatitis (also possibly fatal adverse effect). Clinical trials reported that 0.2% of patients using this drug, had fatal liver failure. Monitoring of liver function (levels of liver enzymes, such as AST and ALT) is recommended during the therapy.
- Immune-mediated dermatitis, including toxic epidermal necrolysis and Stevens-Johnson syndrome have also been reported during clinical trials. 0.2% of patients on Ipilimumab therapy died due to the fatal dermatological adverse reactions. If you're experiencing skin rash or redness of the skin, you should contact your doctor immediately.
- Guillain-Barre syndrome have also been reported during clinical studies. One study that involved 643 patients with metastatic melanoma who were receiving Ipilimumab reported one fatal case due to the Guillain-Barre syndrome. If you're experiencing symptoms, such as: weakness or tingling in your feet, you should contact your doctor immediately.
- Endocrinopathies, such as: hypothyroidism, hypophysitis, hypogonadism and hypopituitarism have also been reported. These adverse reactions may be life-threatening.
Ipilimumab, pregnancy and breastfeeding
Animal studies have shown that Ipilimumab is associated with higher risk of stillbirth, abortion and premature delivery. Therefore, it should be used during pregnancy only if benefits outweigh the risks. Females of reproductive potential should use contraceptive methods during the treatment.
There are no data of its use during breastfeeding, therefore it is not known whether Ipilimumab passes into breast milk or not.
Recommended dosage is 3 mg/kg intravenously over 90 minutes every 21st day (four doses in total).
Ipilimumab may cause following adverse effects:
- Blurred vision
- Vision impairment
- Mood swings
- Weight gain
- Bloody stools
- Diarrhea (most common adverse effect)
- Loss of appetite
- Skin rash