Drug Interaction:
No formal pharmacokinetic drug interaction studies have been conducted with YERVOY
Indication:
YERVOY (ipilimumab) Injection, for intravenous infusion
Initial U.S. Approval: 2011
WARNING: IMMUNE-MEDIATED ADVERSE REACTIONS
See full prescribing information for complete boxed warning.
YERVOY can result in severe and fatal immune-mediated adverse reactions
due to T-cell activation and proliferation.
These immune-mediated reactions may involve any organ system; however,
the most common severe mmune-mediated adverse reactions are enterocolitis,
hepatitis, dermatitis (including toxic epidermal necrolysis), neuropathy,
and endocrinopathy.
The majority of these immune-mediated reactions initially manifested
during treatment; however, a minority occurred weeks to months after
discontinuation of YERVOY.
Permanently discontinue YERVOY and initiate systemic high-dose corticosteroid
therapy for severe immune-mediated reactions.
Assess patients for signs and symptoms of enterocolitis, dermatitis,
neuropathy, and endocrinopathy and evaluate clinical chemistries
including liver function tests and thyroid function tests at baseline and
before each dose.
Drug Name- Yervoy
Active Ingredient - Ipilimumab
To treat patients with late-stage (metastatic) melanoma , the most
dangerous type of skin cancer
Indication-
To treat patients with late-stage (metastatic) melanoma , the most
dangerous type of skin cancer
Approved by FDA on 25-3-2011 (Ref- FDA approved List- 2011)
Adverse Reaction:
Most common adverse reactions (.5%) are fatigue, diarrhea, pruritus, rash, and colitis.
Contra-Indications:
CONTRAINDICATIONS
None.
WARNINGS AND PRECAUTIONS
Immune-mediated adverse reactions: Permanently discontinue for
severe reactions. Withhold dose for moderate immune-mediated
adverse reactions until return to baseline, improvement to mild severity,
or complete resolution, and patient is receiving less than
7.5 mg prednisone or equivalent per day.
Administer systemic high-dose corticosteroids for severe, persistent,
or recurring immune-mediated reactions.
.
Immune-mediated hepatitis: Evaluate liver function tests before each dose
of YERVOY. .
Immune-mediated endocrinopathies: Monitor thyroid function tests
and clinical chemistries prior to each dose.
Evaluate at each visit for signs and symptoms of endocrinopathy.
Institute hormone replacement therapy as needed.
Dosages/ Overdosage Etc:
Indication-
To treat patients with late-stage (metastatic) melanoma , the most
dangerous type of skin cancer
INDICATIONS AND USAGE
YERVOY is a human cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking
antibody indicated for the treatment of unresectable or metastatic melanoma.
DOSAGE AND ADMINISTRATION-
YERVOY 3 mg/kg administered intravenously over 90 minutes every
3 weeks for a total of 4 doses.
. Permanently discontinue for severe adverse reactions.
DOSAGE FORMS AND STRENGTHS
50 mg/10 mL (5 mg/mL)
200 mg/40 mL (5 mg/mL)
Patient Information:
PATIENT COUNSELING INFORMATION
1.Advise the patient to read the FDA-approved patient labeling (Medication Guide).
2.Inform patients of the potential risk of immune-mediated adverse reactions.•
4..Advise patients to read the YERVOY Medication Guide before each YERVOY infusion.
5.Advise women that YERVOY may cause fetal harm.
6.Advise nursing mothers not to breastfeed while taking YERVOY.
Pharmacology/ Pharmacokinetics:
1. Mechanism of Action
CTLA-4 is a negative regulator of T-cell activity. Ipilimumab is a monoclonal
antibody that binds to CTLA-4 and blocks the interaction of CTLA-4 with its ligands,
CD80/CD86. Blockade of CTLA-4 has been shown to augment T-cell activation
and proliferation, including the activation and proliferation of tumor infiltrating
T-effector cells. Inhibition of CTLA-4 signaling can also reduce T-regulatory
cell function, which may contribute to a general increase in T cell responsiveness,
including the anti-tumor immune response.
2. Pharmacokinetics
The pharmacokinetics of ipilimumab were studied in 785 patients with unresectable
or metastatic melanoma who received doses of 0.3, 3, or 10 mg/kg once every
3 weeks for 4 doses. Peak concentration (Cmax), trough concentration (Cmin),
and area under the plasma concentration versus time curve (AUC) of ipilimumab
increased dose proportionally within the dose range
Pregnancy and lactation:
USE IN SPECIFIC POPULATIONS
1. Pregnancy
Pregnancy Category C
There are no adequate and well-controlled studies of YERVOY in pregnant women.
Use YERVOY during pregnancy only if the potential benefit justifies the potential risk to the fetus
2. Nursing Mothers
It is not known whether ipilimumab is secreted in human milk.
Because many drugs are secreted in human milk and because of the
potential for serious adverse reactions in nursing infants from YERVOY,
a decision should be made whether to discontinue nursing or to discontinue YERVOY,
taking into account the importance of YERVOY to the mother.
3. Pediatric Use
The safety and effectiveness of YERVOY have not been established in pediatric patients.
4. Geriatric Use
Of the 511 patients treated with YERVOY at 3 mg/kg, 28% were 65 years and over.
No overall differences in safety or efficacy were reported between the elderly
patients (65 years and over) and younger patients (less than 65 years).
Manufacturer Details