Aa
first trimester tetratogenicity "likelyhood"?
i read the blogs,mfg info and warnings against pregnancy,the registry and 3rd party opinions. but no where do i see,based on pregnancies "known" to date,what the "likelyhood" that a full term pregnancy will result in birth defects,or that miscarriage will occur.just a lot of extrapolating,pontificating,speculating.after all,this med has been used for some time now,pregnancies have occured,babies have been born(or not).any resources showing real time, "to date" data links would be appreciated. i have a family member,3 weeks in treatment,now pregnant.
You should tell your relative " Patients should be advised to notify the healthcare provider immediately in the event of a pregnancy".
This is a very serious issue "ribavirin may cause birth defects and/or death of the exposed fetus" to quote from the ribavirin package insert.
It doesn't get much clearer then this.
From the package insert on Incivek...
http://pi.vrtx.com/files/uspi_telaprevir.pdf
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
INCIVEK safely and effectively. See full prescribing information for
INCIVEK.
• Pregnancy: Use with Ribavirin and Peginterferon alfa: Ribavirin
may cause birth defects and fetal death; avoid pregnancy in female
patients and female partners of male patients. Patients must have a
negative pregnancy test prior to initiating therapy, use at least 2 effective methods of contraception, and undergo monthly pregnancy tests. (5.1, 8.1)
5 WARNINGS AND PRECAUTIONS
5.1 Pregnancy: Use with Ribavirin and Peginterferon Alfa
Ribavirin may cause birth defects and/or death of the exposed fetus. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients. Ribavirin therapy should not be started unless a report of a negative pregnancy test has been obtained immediately prior to initiation of therapy.
Because INCIVEK must be used in combination with peginterferon alfa and ribavirin, the contraindications and warnings applicable to those drugs are applicable to combination therapy. Female patients of childbearing potential and their male partners as well as male patients and their female partners must use 2 effective contraceptive methods during treatment and for 6 months after all treatment has ended. Female patients should have monthly pregnancy tests
during treatment and during the 6-month period after stopping treatment. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients as significant teratogenic and/or embryocidal effects have been demonstrated in all animal species exposed to ribavirin [see Contraindications (4), Use in Specific Populations (8.1), and Patient Counseling Information (17.1)]. Refer also to the prescribing information for ribavirin.
Female Patients
Hormonal contraceptives may be continued but may not be reliable during INCIVEK dosing and for up to two weeks following cessation of INCIVEK [see
Drug Interactions (7)]. During this time, female patients of childbearing potential should use two effective non-hormonal methods of contraception.
Examples may include barrier methods or intrauterine devices (IUDs) [see also Use in Specific Populations: Pregnancy (8.1) and Patient Counseling Information (17.1)]. Two weeks after completion of INCIVEK treatment, hormonal contraceptives are again appropriate as one of the two required effective methods of birth control; however, specific prescribing information recommendations should be followed for the contraceptives.
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Because INCIVEK must be used in combination with ribavirin and peginterferon alfa, the contraindications and warnings applicable to those drugs are applicable to combination treatment. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients.
INCIVEK/Peginterferon Alfa/Ribavirin Combination Treatment
Pregnancy Category X: Animal studies have shown that ribavirin causes birth defects and/or fetal deaths while peginterferon alfa is abortifacient [see Contraindications (4) and Warnings and Precautions (5.1)]. See the prescribing information for ribavirin.
Significant teratogenic and/or embryocidal effects have been demonstrated in all animal species exposed to ribavirin; and therefore ribavirin is contraindicated in women who are pregnant and in the male partners of women who are pregnant [see Contraindications (4),
Warnings and Precautions
(5.1) and ribavirin prescribing information]. Interferons have abortifacient effects in animals and should be assumed to have abortifacient potential in humans (see peginterferon alfa prescribing information).
Extreme caution must be taken to avoid pregnancy in female patients and female partners of male patients while taking this combination. Women of childbearing potential and their male partners should not receive ribavirin unless they are using effective contraception (two reliable forms) during treatment with ribavirin and for 6 months after treatment. Systemic hormonal contraceptives may not be as effective in women while taking INCIVEK.
Therefore, two alternative effective methods of contraception, including intrauterine devices and barrier methods, should be used in women during treatment with INCIVEK and concomitant ribavirin [see Warnings and Precautions (5.1)]. A Ribavirin Pregnancy Registry has been established to monitor maternal-fetal outcomes of pregnancies in female patients and female partners of male patients exposed to ribavirin during treatment and for 6 months following cessation of treatment. Health care providers and patients are encouraged to report such cases by calling 1-800-593-2214.
INCIVEK (telaprevir) Tablets
Pregnancy Category B: Telaprevir treatment alone in mice and rats did not result in harm to the fetus. The highest doses tested produced exposures equal to 1.84- and 0.60-fold the exposures in humans at the recommended clinical dose, respectively. Telaprevir treatment alone had effects on fertility parameters in rats. The no observed adverse effect level (NOAEL) for testicular toxicity was established at exposures 0.17-fold the human exposures at the recommended
clinical dose. Potential effects on sperm (e.g., decreased % motile sperm and increased non-motile sperm count) were observed in a rat fertility study at exposures 0.30-fold the human exposures at the recommended clinical dose. Additional effects on fertility include minor increases in percent preimplantation loss, in percent of dams with nonviable embryos and percent of nonviable conceptuses per litter. These effects are likely associated with testicular toxicity in male but contributions of the female cannot be ruled out. There are, however, no adequate and well-controlled studies in pregnant
women. Significant teratogenic and/or embryocidal effects have been demonstrated in all animal species exposed to ribavirin. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients—both during treatment and for 6 months after the completion of all treatment.
INCIVEK combination treatment should not be started unless a female patient has a negative pregnancy test immediately prior to initiation of treatment.
Pregnancy testing should occur monthly during INCIVEK combination treatment and for 6 months after all treatment has ended [see Contraindications (4)
and Patient Counseling Information (17.1)]. Pregnancy testing in non-pregnant female partners is recommended before INCIVEK combination therapy, every month during INCIVEK combination therapy, and for 6 months after ribavirin therapy has ended.
----------------------------------------------------------------------------------------
Cheers!
Hector
This is a very serious issue "ribavirin may cause birth defects and/or death of the exposed fetus" to quote from the ribavirin package insert.
It doesn't get much clearer then this.
From the package insert on Incivek...
http://pi.vrtx.com/files/uspi_telaprevir.pdf
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
INCIVEK safely and effectively. See full prescribing information for
INCIVEK.
• Pregnancy: Use with Ribavirin and Peginterferon alfa: Ribavirin
may cause birth defects and fetal death; avoid pregnancy in female
patients and female partners of male patients. Patients must have a
negative pregnancy test prior to initiating therapy, use at least 2 effective methods of contraception, and undergo monthly pregnancy tests. (5.1, 8.1)
5 WARNINGS AND PRECAUTIONS
5.1 Pregnancy: Use with Ribavirin and Peginterferon Alfa
Ribavirin may cause birth defects and/or death of the exposed fetus. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients. Ribavirin therapy should not be started unless a report of a negative pregnancy test has been obtained immediately prior to initiation of therapy.
Because INCIVEK must be used in combination with peginterferon alfa and ribavirin, the contraindications and warnings applicable to those drugs are applicable to combination therapy. Female patients of childbearing potential and their male partners as well as male patients and their female partners must use 2 effective contraceptive methods during treatment and for 6 months after all treatment has ended. Female patients should have monthly pregnancy tests
during treatment and during the 6-month period after stopping treatment. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients as significant teratogenic and/or embryocidal effects have been demonstrated in all animal species exposed to ribavirin [see Contraindications (4), Use in Specific Populations (8.1), and Patient Counseling Information (17.1)]. Refer also to the prescribing information for ribavirin.
Female Patients
Hormonal contraceptives may be continued but may not be reliable during INCIVEK dosing and for up to two weeks following cessation of INCIVEK [see
Drug Interactions (7)]. During this time, female patients of childbearing potential should use two effective non-hormonal methods of contraception.
Examples may include barrier methods or intrauterine devices (IUDs) [see also Use in Specific Populations: Pregnancy (8.1) and Patient Counseling Information (17.1)]. Two weeks after completion of INCIVEK treatment, hormonal contraceptives are again appropriate as one of the two required effective methods of birth control; however, specific prescribing information recommendations should be followed for the contraceptives.
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Because INCIVEK must be used in combination with ribavirin and peginterferon alfa, the contraindications and warnings applicable to those drugs are applicable to combination treatment. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients.
INCIVEK/Peginterferon Alfa/Ribavirin Combination Treatment
Pregnancy Category X: Animal studies have shown that ribavirin causes birth defects and/or fetal deaths while peginterferon alfa is abortifacient [see Contraindications (4) and Warnings and Precautions (5.1)]. See the prescribing information for ribavirin.
Significant teratogenic and/or embryocidal effects have been demonstrated in all animal species exposed to ribavirin; and therefore ribavirin is contraindicated in women who are pregnant and in the male partners of women who are pregnant [see Contraindications (4),
Warnings and Precautions
(5.1) and ribavirin prescribing information]. Interferons have abortifacient effects in animals and should be assumed to have abortifacient potential in humans (see peginterferon alfa prescribing information).
Extreme caution must be taken to avoid pregnancy in female patients and female partners of male patients while taking this combination. Women of childbearing potential and their male partners should not receive ribavirin unless they are using effective contraception (two reliable forms) during treatment with ribavirin and for 6 months after treatment. Systemic hormonal contraceptives may not be as effective in women while taking INCIVEK.
Therefore, two alternative effective methods of contraception, including intrauterine devices and barrier methods, should be used in women during treatment with INCIVEK and concomitant ribavirin [see Warnings and Precautions (5.1)]. A Ribavirin Pregnancy Registry has been established to monitor maternal-fetal outcomes of pregnancies in female patients and female partners of male patients exposed to ribavirin during treatment and for 6 months following cessation of treatment. Health care providers and patients are encouraged to report such cases by calling 1-800-593-2214.
INCIVEK (telaprevir) Tablets
Pregnancy Category B: Telaprevir treatment alone in mice and rats did not result in harm to the fetus. The highest doses tested produced exposures equal to 1.84- and 0.60-fold the exposures in humans at the recommended clinical dose, respectively. Telaprevir treatment alone had effects on fertility parameters in rats. The no observed adverse effect level (NOAEL) for testicular toxicity was established at exposures 0.17-fold the human exposures at the recommended
clinical dose. Potential effects on sperm (e.g., decreased % motile sperm and increased non-motile sperm count) were observed in a rat fertility study at exposures 0.30-fold the human exposures at the recommended clinical dose. Additional effects on fertility include minor increases in percent preimplantation loss, in percent of dams with nonviable embryos and percent of nonviable conceptuses per litter. These effects are likely associated with testicular toxicity in male but contributions of the female cannot be ruled out. There are, however, no adequate and well-controlled studies in pregnant
women. Significant teratogenic and/or embryocidal effects have been demonstrated in all animal species exposed to ribavirin. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients—both during treatment and for 6 months after the completion of all treatment.
INCIVEK combination treatment should not be started unless a female patient has a negative pregnancy test immediately prior to initiation of treatment.
Pregnancy testing should occur monthly during INCIVEK combination treatment and for 6 months after all treatment has ended [see Contraindications (4)
and Patient Counseling Information (17.1)]. Pregnancy testing in non-pregnant female partners is recommended before INCIVEK combination therapy, every month during INCIVEK combination therapy, and for 6 months after ribavirin therapy has ended.
----------------------------------------------------------------------------------------
Cheers!
Hector
Ribavirin dosing label states categorically that the drug "may " be harmful to the fetus" .If your family member chooses to ignore drug warnings ..that would be a personal choice.I don"t believe many others would take that risk in such an important matter.
I don"t personally know of anybody that had a child with birth defects from doing HCV therapy .. but that is more than likely because you would think most people adhere to the danger warnings. and not experimenting otherwise....
.
Often it is not necessary to have actual cases to know that a chemical is toxic to a developing fetus.
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