Olaratumab- Lartruvo-@- (Oct 2016)- Anti-cancer
Drug Name:Olaratumab- Lartruvo-@- (Oct 2016)- Anti-cancer
List Of Brands:
Indication Type Description:
Indication
Adverse Reaction
Contra-Indications
Dosages/ Overdosage Etc
Patient Information
Pharmacology/ Pharmacokinetics
Pregnancy and lactation
Indication:
DRUG INNOVATION - NOVEL DRUG APPROVALS FOR 2016
No Drug Name Active Ingredient Approval Date FDA-Approved use
on Approval date
18. Lartruvo Olaratumab 10/19/2016
To treat adults with certain types of soft tissue sarcoma
Press release
Approved by FDA on 10/19/2016 (Ref- FDA approved List- 2016)
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
LARTRUVO safely and effectively. See full prescribing
information for LARTRUVO.
LARTRUVO (olaratumab) injection, for intravenous use
Initial U.S. Approval: 2016
INDICATIONS AND USAGE
LARTRUVO™ is a platelet-derived growth factor receptor alpha (PDGFR-a)
blocking antibody indicated, in combination with doxorubicin, for the
treatment of adult patients with soft tissue sarcoma (STS) with a histologic
subtype for which an anthracycline-containing regimen is appropriate and
which is not amenable to curative treatment with radiotherapy or surgery.
This indication is approved under accelerated approval. Continued
approval for this indication may be contingent upon verification and
description of clinical benefit in the confirmatory trial.
Adverse Reaction:
ADVERSE REACTIONS
The most common (=20%) adverse reactions of LARTRUVO plus doxorubicin
are nausea, fatigue, musculoskeletal pain, mucositis,alopecia, vomiting,
diarrhea, decreased appetite, abdominal pain,neuropathy, and headache.
The most common (=20%) laboratory abnormalities were lymphopenia,
neutropenia, thrombocytopenia, hyperglycemia, elevated aPTT,
hypokalemia, and hypophosphatemia.
Contra-Indications:
CONTRAINDICATIONS
None.
WARNINGS AND PRECAUTIONS
Infusion-Related Reactions: Monitor for signs and symptoms during and
following infusion. Discontinue LARTRUVO for Grade 3 or 4 infusion-related
reactions.
Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of potential
risk to the fetus and to use effective contraception during treatment with
LARTRUVO and for 3 months after the last dose.
Dosages/ Overdosage Etc:
INDICATIONS AND USAGE
LARTRUVO™ is a platelet-derived growth factor receptor alpha (PDGFR-a)
blocking antibody indicated, in combination with doxorubicin, for the
treatment of adult patients with soft tissue sarcoma (STS) with a histologic
subtype for which an anthracycline-containing regimen is appropriate and
which is not amenable to curative treatment with radiotherapy or surgery.
This indication is approved under accelerated approval. Continued
approval for this indication may be contingent upon verification and
description of clinical benefit in the confirmatory trial.
DOSAGE AND ADMINISTRATION
Administer LARTRUVO at 15 mg/kg as an intravenous infusion over
60 minutes on Days 1 and 8 of each 21-day cycle until disease
For the first 8 cycles, LARTRUVO is administered with doxorubicin.
Premedicate with diphenhydramine and dexamethasone
intravenously, prior to LARTRUVO on Day 1 of cycle 1.
For intravenous infusion only. Do not administer as an intravenous
push or bolus.
DOSAGE FORMS AND STRENGTHS
Injection: 500 mg/50 mL (10 mg/mL) solution in a single-dose vial
Patient Information:
PATIENT COUNSELING INFORMATION
Infusion-Related Reactions
Advise patients to report signs and symptoms of infusion reactions.Refer
Refer-Warnings and Precautions
Embryo-Fetal Toxicity
Advise pregnant women of the potential risk to the fetus. Advise females of
reproductive potential of the potential risk to the fetus, to use effective
contraception during treatment with LARTRUVO and for 3 months after the
last dose, and to inform their healthcare provider of a known or suspected
pregnancy
Lactation
Advise patients not to breastfeed during treatment with LARTRUVO and for
3 months after the last dose.
Eli Lilly and Company, Indianapolis, IN 46285, USA
US License No. 1891
Copyright © 2016, Eli Lilly and Company. All rights reserved.
Pharmacology/ Pharmacokinetics:
CLINICAL PHARMACOLOGY
1. Mechanism of Action
Olaratumab is a human IgG1 antibody that binds platelet-derived growth factor
receptor alpha (PDGFR-a). PDGFR-a is a receptor tyrosine kinase expressed
on cells of mesenchymal origin.
Signaling through this receptor plays a role in cell growth, chemotaxis, and
mesenchymal stem cell differentiation. The receptor has also been detected on
some tumor and stromal cells, including sarcomas, where signaling can
contribute to cancer cell proliferation, metastasis, and maintenance of the tumor
microenvironment.
2.Pharmacokinetics
Distribution
The volume of distribution (CV%) at steady-state (Vss) is 7.7 L (16%).
Elimination
The mean clearance (CV%) for olaratumab was 0.56 L/day (33%). The estimated
elimination half-life was approximately 11 days (range 6 to 24 days)
Pregnancy and lactation:
USE IN SPECIFIC POPULATIONS
1. Pregnancy
Risk Summary
Based on animal data and its mechanism of action, LARTRUVO can cause fetal
harm.
There are no available data on LARTRUVO use in pregnant women. No animal
studies using olaratumab have been conducted to evaluate its effect on female
reproduction and embryo-fetal development.
In the U.S. general population, the estimated background risk of major birth defects
and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%
respectively.
2. Lactation
Risk Summary
There are no data on the presence of olaratumab in human milk, or its effects on
the breastfed infant or on milk production. Because of the potential risk for serious
adverse reactions in breastfeeding infants from olaratumab, advise women not to
breastfeed during treatment with LARTRUVO and for 3 months following the last
dose.
3. Pediatric Use
The safety and effectiveness of LARTRUVO in pediatric patients have not been
established.
4. Geriatric Use
Clinical studies of LARTRUVO did not include sufficient numbers of patients aged
65 years and older to determine whether they respond differently from younger
patients.
