Yervoy Injection
Ipilimumab
5mg/ml
Bristol Myers Squibb Company
| Pack size | 40ml Glass Vial |
|---|---|
| Dispensing mode | POM |
| Source | USA |
| Agent | Modern Pharmaceutical Co. |
| Retail Price | 110251.50 AED |
Available as:
Indications
Yervoy Injection is used for:
Metastatic melanoma, Renal Cell Carcinoma
Adult Dose
Intravenous
Metastatic melanoma
Adult: 3 mg/kg via infusion over 90 minutes every 3 weeks for a total of 4 doses. In case of toxicity, doses may be delayed, but all treatment must be given within 16 weeks of 1st dose.
Melanoma
Adult: As adjuvant therapy in patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of >1 mm who have undergone complete resection: 10 mg/kg via infusion over 90 minutes every 3 weeks for a total of 4 doses then, 10 mg/kg every 12 weeks for up to 3 years or until documented disease recurrence or unacceptable toxicity. In case of toxicity, omit dose/s.
Renal Cell Carcinoma
Indicated in combination with nivolumab for patients with intermediate or poor risk, previously untreated advanced renal cell carcinoma
1 mg/kg IV infused over 30 min immediately following nivolumab on the same day; repeat q3Weeks for up to 4 doses or until intolerable toxicity or disease progression
Child Dose
Intravenous
Metastatic melanoma
Child: >12 years: 3 mg/kg via infusion over 90 minutes every 3 weeks for a total of 4 doses. In case of toxicity, doses may be delayed, but all treatment must be given within 16 weeks of 1st dose.
Renal Dose
Administration
V Preparation
Dilute with 0.9% NaCl or D5W to prepare a diluted solution with a final concentration ranging from 1-2 mg/mL
Mix diluted solution by gentle inversion
IV Administration
Do not mix with, or administer as an infusion with, other medicinal products
Flush the IV line with 0.9% NaCl or D5W after each dose.
Administer diluted solution over 90 minutes (melanoma) or 30 minutes (renal cell carcinoma) through an IV line containing a sterile, nonpyrogenic, low-protein-binding in-line filter
Administration with nivolumab
When administered in combination with nivolumab, infuse nivolumab first followed by ipilimumab on the same day
Use separate infusion bags and filters for each infusion
Contra Indications
No known contraindications
Precautions
May cause immune-mediated adverse reactions including enterocolitis, hepatitis, dermatitis, neuropathies, endocrinopathies, ocular, and other significant or severe immune-mediated manifestations; may require initiation of systemic corticosteroids at a dose of 1 to 2 mg/kg/day of prednisone or equivalent
Monitor patients for signs or symptoms of ocular toxicity, which may include blurred vision and reduced visual acuity; immune-mediated ocular toxicity may be associated with retinal detachment or permanent vision loss; administer corticosteroid eye drops to patients who develop uveitis, iritis, or episcleritis; permanently discontinue therapy for immune-mediated ocular disease that is unresponsive to local immunosuppressive therapy; if uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt Koyanagi-Harada-like syndrome, which has been observed in patients receiving drug and may require treatment with systemic steroids to reduce the risk of permanent vision loss
Withhold dose for moderate immune-mediated adverse reactions until return to baseline, improvement to mild severity, or complete resolution, and patient is receiving <7.5 mg/day prednisone or equivalent
Administer systemic high-dose corticosteroids for severe, persistent, or recurring immune-mediated reactions
Evaluate liver function tests before each dose; permanently discontinue with Grade 3-4 hepatotoxicity
Monitor thyroid function tests and clinical chemistries prior to each dose
Evaluate at each visit for signs and symptoms of endocrinopathy and institute hormone replacement therapy as needed
Patient with history of autoimmune disease. Children. Pregnancy and lactation.
Lactation
Unknown whether distributed in human breast milk
Advise women to discontinue nursing during treatment and for 3 months after the final dose
There are no data to assess the effects on milk production
Pregnancy-Lactation
Pregnancy
Based on data from animal studies and its mechanism of action, can cause fetal harm when administered to a pregnant woman
Advise females of reproductive potential to use effective contraception during treatment and for 3 months after the last dose
Human IgG1 is known to cross the placental barrier and ipilimumab is an IgG1; therefore, ipilimumab has the potential to be transmitted from the mother to the developing fetus
Animal studies
In animal reproduction studies, administration of ipilimumab to cynomolgus monkeys from the onset of organogenesis through delivery resulted in higher incidences of abortion, stillbirth, premature delivery (with corresponding lower birth weight), and higher incidences of infant mortality in a dose-related manner
The effects are likely to be greater during the second and third trimesters of pregnancy
Lactation
Unknown whether distributed in human breast milk
Advise women to discontinue nursing during treatment and for 3 months after the final dose
In monkeys, ipilimumab was present in milk
There are no data to assess the effects on milk production
Interactions
May increase hepatotoxicity of vemurafenib.
Adverse Effects
Side effects of Ipilimumab :
>10%
Dermatitis immune-mediated manifestations (up to 70%)
Fatigue (41%)
Diarrhea (32%)
Pruritus (31%)
Rash (29%)
1-10%
Colitis (8%)
Immune-mediated enterocolitis (7%)
Immune-mediated hepatitis (2%)
Endocrinopathies (1.8%) including adrenal insufficiency, hypogonadism, and hypothyroidism
<1%
Neurologic immune-mediated manifestations (eg, Guillain-Barre, peripheral motor neuropathy)
Ocular immune-mediated manifestations (eg, uveitis, iritis)
Nephrotic immune-mediated manifestations (nephritis)
Pulmonary immune-mediated manifestations (pneumonitis)
Other immune-mediated adverse reactions (<1%) include nephritis, pneumonitis, meningitis, pericarditis, uveitis, iritis, and hemolytic anemia
Meningitis
Pericarditis
Myocarditis
Angiopathy
Temporal arteritis
Vasculitis
Polymyalgia rheumatica
Conjunctivitis
Blepharitis
Episcleritis
Scleritis
Leukocytoclastic vasculitis
Erythema multiforme
Psoriasis
Pancreatitis
Arthritis
Autoimmune thyroiditis
Mechanism of Action
Ipilimumab, an antineoplastic drug, is a recombinant, fully human monoclonal antibody. It inhibits cytotoxic-T-lymphocyte-associated antigen 4 (CTLA-4), a down-regulator of T-cell activation pathways, thereby prolonging T-cell activation and proliferation and enhancing anti-tumour immune response. It may also decrease T-regulatory cell function and increase T cell responsiveness.
Note
Yervoy 5mg/ml Injection manufactured by Bristol Myers Squibb Company. Its generic name is Ipilimumab. Yervoy is availble in United Arab Emirates.
Farmaco UAE drug index information on Yervoy Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.