Approved Drug Label (PDF)
5
Warnings and Precautions
(PLR
conversion: subsections created as below, please see label for complete
information)
5.1 Secondary Malignancy or Leukemia
5.2 Veno-occlusive Disease
5.3 Extravasation
5.4 Myelosuppression
5.5 Immunizations
5.6 Severe Mucocutaneous Reactions
5.7 Renal Toxicity
5.8 Hepatotoxicity
5.9 Potentiation of Radiation Toxicity and
Radiation Recall
5.10 Embryo-Fetal Toxicity
6
Adverse Reactions
(PLR
conversion, please see label for more information)
8
Use in Specific Populations
8.1 Pregnancy
(PLLR
conversion)
Risk Summary
Based on findings from animal studies and its mechanism
of action, COSMEGEN can cause fetal harm when administered to a pregnant woman.In animal reproduction studies,
administration of dactinomycin to pregnant animals during the period of
organogenesis was teratogenic, resulting in malformations at doses lower than
the recommended human dose (see Data).
Advise pregnant women of the potential risk to a fetus.
In the U.S. general population, the estimated background
risk of major birth defects and miscarriage in clinically recognized
pregnancies is 2% to 4% and 15% to 20%, respectively.
Data
Animal
Data
Dactinomycin was teratogenic in animals. Administration
of dactinomycin to pregnant rats, rabbits, and hamsters during the period of
organogenesis, increased the incidence of fetal malformations and caused
embryotoxicity at doses (based on body surface area) as low as 0.2 times the
clinical dose of 1250 mcg/m2.
8.2 Lactation
(PLLR
conversion)
Risk Summary
There are no data on the presence of dactinomycin or its
metabolites in human milk or their effects on the breastfed infant or on milk
production. Because of the potential for serious adverse reactions in breastfed
infants from COSMEGEN, advise women not to breastfeed during treatment with
COSMEGEN and, based on limited published data regarding the dactinomycin
half-life, for 14 days after the final dose.
8.3 Females and Males of Reproductive Potential
(PLLR conversion)
Pregnancy Testing
Verify the pregnancy status of females of reproductive
potential prior to initiating COSMEGEN.
Contraception
COSMEGEN can cause fetal harm when administered to a
pregnant woman.
Females
Advise females of reproductive potential to use effective
contraception during treatment with COSMEGEN and for at least 6 months after
the final dose.
Males
Because of the potential for genotoxicity, advise males
with female partners of reproductive potential to use effective contraception
during treatment with COSMEGEN and for 3 months after the final dose.
8.4 Pediatric Use
(additions underlined)
The safety and effectiveness
of dactinomycin have been established in pediatric patients with Wilms tumor,
rhabdomyosarcoma, Ewing sarcoma, and metastatic nonseminomatous testicular
cancer.
The safety and effectiveness
of dactinomycin have been established in post-menarchal pediatric patients with
gestational trophoblastic neoplasia.
The safety and effectiveness
of COSMEGEN have not been established in pediatric patients undergoing regional
perfusion for locally recurrent or locoregional solid malignancies.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING INFORMATION
(PLR
conversion; new subsection added)
Secondary Malignancy or Leukemia
Advise patients of the increased risk of secondary
malignancies.
Veno-occlusive Disease
Advise patients about the symptoms of VOD and to seek
medical attention if they develop new onset jaundice, abdominal distention, or
right upper quadrant pain.
Myelosuppression
Advise patients to contact their healthcare provider for
any signs or symptoms of myelosuppression or infection.
Severe Mucocutaneous Reactions
Advise patients of the risk of severe mucocutaneous
reactions and to contact their health care provided for new skin lesions, mouth
sores or oropharyngeal lesions.
Renal Toxicity or Hepatotoxicity
Advise patients of the need for periodic laboratory
testing to monitor for renal toxicity and hepatotoxicity.
Potentiation of Radiation Toxicity and
Radiation Recall
Advise patients of the risk of increased
radiation-induced gastrointestinal, myelosuppression and skin toxicity.
Embryo-Fetal Toxicity
Advise females of reproductive potential of the potential
risk to a fetus. Advise females to inform their healthcare provider of a known
or suspected pregnancy.
Advise females of reproductive potential to use effective
contraception during treatment with COSMEGEN and for 6 months after final dose.
Advise male patients with female partners of reproductive
potential to use effective contraception during treatment with COSMEGEN and for
3 months after final dose.
Lactation
Advise females not to breastfeed during treatment with
COSMEGEN and for 14 days after the final dose.
Other
Approved Drug Label (PDF)
5
Warnings and Precautions
(PLR
conversion: subsections created as below, please see label for complete
information)
5.1 Secondary Malignancy or Leukemia
5.2 Veno-occlusive Disease
5.3 Extravasation
5.4 Myelosuppression
5.5 Immunizations
5.6 Severe Mucocutaneous Reactions
5.7 Renal Toxicity
5.8 Hepatotoxicity
5.9 Potentiation of Radiation Toxicity and
Radiation Recall
5.10 Embryo-Fetal Toxicity
6
Adverse Reactions
(PLR
conversion, please see label for more information)
8
Use in Specific Populations
8.1 Pregnancy
(PLLR
conversion)
Risk Summary
Based on findings from animal studies and its mechanism
of action, COSMEGEN can cause fetal harm when administered to a pregnant woman.In animal reproduction studies,
administration of dactinomycin to pregnant animals during the period of
organogenesis was teratogenic, resulting in malformations at doses lower than
the recommended human dose (see Data).
Advise pregnant women of the potential risk to a fetus.
In the U.S. general population, the estimated background
risk of major birth defects and miscarriage in clinically recognized
pregnancies is 2% to 4% and 15% to 20%, respectively.
Data
Animal
Data
Dactinomycin was teratogenic in animals. Administration
of dactinomycin to pregnant rats, rabbits, and hamsters during the period of
organogenesis, increased the incidence of fetal malformations and caused
embryotoxicity at doses (based on body surface area) as low as 0.2 times the
clinical dose of 1250 mcg/m2.
8.2 Lactation
(PLLR
conversion)
Risk Summary
There are no data on the presence of dactinomycin or its
metabolites in human milk or their effects on the breastfed infant or on milk
production. Because of the potential for serious adverse reactions in breastfed
infants from COSMEGEN, advise women not to breastfeed during treatment with
COSMEGEN and, based on limited published data regarding the dactinomycin
half-life, for 14 days after the final dose.
8.3 Females and Males of Reproductive Potential
(PLLR conversion)
Pregnancy Testing
Verify the pregnancy status of females of reproductive
potential prior to initiating COSMEGEN.
Contraception
COSMEGEN can cause fetal harm when administered to a
pregnant woman.
Females
Advise females of reproductive potential to use effective
contraception during treatment with COSMEGEN and for at least 6 months after
the final dose.
Males
Because of the potential for genotoxicity, advise males
with female partners of reproductive potential to use effective contraception
during treatment with COSMEGEN and for 3 months after the final dose.
8.4 Pediatric Use
(additions underlined)
The safety and effectiveness
of dactinomycin have been established in pediatric patients with Wilms tumor,
rhabdomyosarcoma, Ewing sarcoma, and metastatic nonseminomatous testicular
cancer.
The safety and effectiveness
of dactinomycin have been established in post-menarchal pediatric patients with
gestational trophoblastic neoplasia.
The safety and effectiveness
of COSMEGEN have not been established in pediatric patients undergoing regional
perfusion for locally recurrent or locoregional solid malignancies.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING INFORMATION
(PLR
conversion; new subsection added)
Secondary Malignancy or Leukemia
Advise patients of the increased risk of secondary
malignancies.
Veno-occlusive Disease
Advise patients about the symptoms of VOD and to seek
medical attention if they develop new onset jaundice, abdominal distention, or
right upper quadrant pain.
Myelosuppression
Advise patients to contact their healthcare provider for
any signs or symptoms of myelosuppression or infection.
Severe Mucocutaneous Reactions
Advise patients of the risk of severe mucocutaneous
reactions and to contact their health care provided for new skin lesions, mouth
sores or oropharyngeal lesions.
Renal Toxicity or Hepatotoxicity
Advise patients of the need for periodic laboratory
testing to monitor for renal toxicity and hepatotoxicity.
Potentiation of Radiation Toxicity and
Radiation Recall
Advise patients of the risk of increased
radiation-induced gastrointestinal, myelosuppression and skin toxicity.
Embryo-Fetal Toxicity
Advise females of reproductive potential of the potential
risk to a fetus. Advise females to inform their healthcare provider of a known
or suspected pregnancy.
Advise females of reproductive potential to use effective
contraception during treatment with COSMEGEN and for 6 months after final dose.
Advise male patients with female partners of reproductive
potential to use effective contraception during treatment with COSMEGEN and for
3 months after final dose.
Lactation
Advise females not to breastfeed during treatment with
COSMEGEN and for 14 days after the final dose.
Other
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