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Femara


Forum: Trying to Conceive with Medical Assistance

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  #1  
February 7th, 2006, 12:15 PM
Katlynsmommy's Avatar Platinum Supermommy
Join Date: Jun 2005
Location: Clearwater Florida
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USAGE:
This medication is used to treat advanced breast cancer in women after menopause (change of life).


HOW TO USE
Take by mouth once daily with or without food or as directed. Do not stop taking this medication unless instructed to do so by your doctor or pharmacist. Continue to take your other medications unless instructed otherwise.
Learn more

SIDE EFFECTS:
This drug is generally well tolerated. Fatigue, nausea, constipation, diarrhea, headache, drowsiness or dizziness may occur. If these persist or worsen, notify your doctor promptly.

Unlikely but report promptly: chest pain, stomach pain, trouble breathing, hot flushes, rash, itching.

Very unlikely but report promptly: swelling/redness/weakness/ pain in legs or arms, vision problems, unusual vaginal bleeding.

If you notice other effects not listed above, contact your doctor or pharmacist.
Learn more

PRECAUTIONS:
Tell your doctor your medical history, especially of: liver problems, allergies (especially drug allergies).

Limit alcohol intake as it may increase the side effects of this drug.

Caution performing tasks requiring mental alertness (e.g., driving), since it is possible this drug may cause drowsiness.

This drug is not recommended for use during pregnancy. Consult your doctor for details.

It is not known if this drug is excreted into breast milk. Consult your doctor before breast-feeding.


DRUG INTERACTIONS:
Tell your doctor of all nonprescription and prescription medication you may use, especially of drugs that cause drowsiness such as: sedatives, tranquilizers, psychiatric medications, certain cough-and-cold products containing antihistamines (e.g., diphenhydramine), anti-seizure drugs, muscle relaxants, narcotic pain relievers (e.g., codeine).

Do not start or stop any medicine without doctor or pharmacist approval.
Learn more

OVERDOSE:
If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly.


NOTES:
Do not share this medication with others.

MISSED DOSE:
If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not "double-up" the dose to catch up.

Femara Oral is used to treat the following:
Postmenopausal Advanced Breast Cancer Post-Antiestrogen Therapy, Hormone Receptor Positive Postmenopausal Advanced Breast Cancer, Hormone Receptor Positive Postmenopausal Early Breast Cancer After Adjuvant Tamoxifen, Breast Cancer that has Spread to Another Part of the Body
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  #2  
October 11th, 2006, 07:34 PM
Super Mommy
Join Date: Mar 2005
Location: now Nova Scotia
Posts: 958
I just wanted to add the following that I found tonight:

This is duplicated text of a letter from Novartis Pharmaceuticals Canada Inc. Contact the company for a copy of any references, attachments or enclosures.

November 17, 2005

Dear Health Care Professional:

Subject: Contraindication of Femara* (letrozole) in premenopausal women

Following discussions with Health Canada, Novartis is advising you of concerns about the use of the aromatase inhibitor Femara* (letrozole) for the purpose of ovulation induction in the treatment of infertility. Novartis is aware that Femara* has been or is being used to treat infertility even though statements in the Canadian Product Monographs warn physicians about potential embryo- and fetotoxicity with or without teratogenicity. There have been post-market reports of congenital anomalies in infants of mothers exposed to Femara* for the treatment of infertility.

Femara* (letrozole) is contraindicated in women with premenopausal endocrine status, in pregnancy, and/or lactation due to the potential for maternal and fetal toxicity and fetal malformations.

Novartis is committed to the safe use of its medications. As a manufacturer and distributor of Femara* (letrozole), it is our regulatory and compliance responsibility to duly remind all concerned physicians that the use of letrozole for the purpose of ovulation induction is not within the scope of the approved indications. For your information, the approved indications for Femara* and important information on contraindications and reproductive toxicology are described below:

Extracted from the respective Femara* (letrozole) Product Monographs dated March 22, 2004 and Sept. 22, 2005:

Indications and Clinical Use
Femara* (letrozole) is indicated for the treatment of first-line therapy in postmenopausal women with advanced breast cancer. It is also indicated for the hormonal treatment of advanced/metastatic breast cancer in women with natural or artificially-induced postmenopausal status, who have disease progression following antiestrogen therapy.

Femara* (letrozole) is also indicated for use in the extended adjuvant treatment of hormone receptor-positive early breast cancer in postmenopausal women who have received approximately 5 years of prior standard adjuvant tamoxifen therapy.


Contraindications
Femara* (letrozole) is contraindicated in premenopausal endocrine status, pregnancy, and lactation.


Warnings
Reproductive Toxicology
Letrozole was evaluated for maternal toxicity as well as embryotoxic, fetotoxic and teratogenic potential in female rats following oral administration of daily doses of 0.003, 0.01 or 0.03 mg/kg on gestation days 6 through 17. Oral administration of letrozole to pregnant rats resulted in teratogenicity and maternal toxicity at 0.03 mg/kg. Embryotoxicity and fetotoxicity were seen at doses ≥ 0.003 mg/kg and there was an increase in the incidence of fetal malformation among the animals treated. However it is not known whether this was an indirect consequence of the pharmacological activity of Femara* (inhibition of estrogen biosynthesis) or a direct drug effect.
Novartis recommends the use of Femara* within the labeled indications. Your professional commitment in this regard has an important role in protecting the well being of your patients.

The identification, characterization, and management of marketed health product-related adverse reactions are dependent on the active participation of health care professionals in adverse drug reaction reporting programmes. Reporting rates determined on the basis of spontaneously reported post-marketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments.

Health Canada depends on health care professionals to report any fetal or maternal toxicity or any other serious and/or unexpected adverse reactions in patients receiving Femara* to Novartis or Health Canada at the following addresses:

Novartis Pharmaceuticals Canada Inc.
385 Bouchard Blvd.
Dorval, (QC) H9S 1A9
Phone:1-800-363-8883 (Medical information)

Any suspected adverse reaction can also be reported to:
Canadian Adverse Drug Reaction Monitoring Program (CADRMP)
Marketed Health Products Directorate
HEALTH CANADA
Address Locator: 0701C
Ottawa, Ontario K1A 0K9
Tel: (613) 957-0337 or Fax: (613) 957-0335
To report an Adverse Reaction, consumers and health professionals may call toll free:
Tel: 866 234-2345
Fax: 866 678-6789
cadrmp@hc-sc.gc.ca

The AR Reporting Form and the AR Guidelines can be found on the Health Canada web site or in The Canadian Compendium of Pharmaceuticals and Specialties.

For other inquiries related to this communication, please contact Health Canada at:
Marketed Health Products Directorate
MHPD_DPSC@hc-sc.gc.ca
Tel: (613) 954-6522
Fax: (613) 952-7738



For the full prescribing information consult the Novartis website at:
http://www.novartis.ca

Should you have any questions or require additional information regarding the use of Femara* (letrozole) please contact Novartis Pharmaceuticals Canada Inc., at 1-800-363-8883 from 8:30 AM to 4:30 PM Monday to Friday Eastern Standard Time.

Novartis Pharmaceuticals Canada Inc.

original signed by

Pier-Giorgio Fontana, PhD
Vice-President
Regulatory Affairs Jean-Marie Leclerc, M.D. FRCP ©
Chief Scientific Officer
and Senior Vice-President Clinical
and Regulatory Affairs

Pr Femara* is a registered trademark
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Michelle - 41 (formerly known as mommie2be1966)
Glenn - 44

Good things come to those who wait



Low and slow betas (possible blighted ovum)
July 4: BFP - EDD March 9/09
July 7: 538
July 11: 1134
July 14: 1782
u/s July 21 @ 2:15 pm - blighted ovum, d&c to be scheduled
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  #3  
May 24th, 2007, 05:48 PM
KittyMom's Avatar Mega Super Mommy
Join Date: Sep 2006
Location: Canada, eh?
Posts: 2,429
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Here is some great info links on Femara/Letrozole. The Fertility clinic I go to is using it more and more over Clomid with great success rates. The original study relased did not include some major details showing that the incidence of birth defects using Femara as compared to Clomid are almost identical (actually slightly less in Femara). Like any fertility drug, it should NOT be taken while pregnant as this is where the birth defects come into play.

1) “A randomized trial of letrozole versus clomiphene citrate in women undergoing superovulation. “


December 2004 study comparing the effectiveness of clomid and femara. Based on number of follicles, endometrial thickness, pregnancy rate, and miscarriage rate. They had similar pregnancy rates, but the rate of miscarriage was higher with clomid.

http://www.ncbi.nlm.nih.gov.libproxy.lib.u...l=pubmed_doc sum


2) “A randomized trial of superovulation with two different doses of letrozole.’

Jan 2006 study comparing a 2.5 mg dose and a 5.0 mg dose of femara. Factors were number of follicles, endometrial thickness, and pregnancy rate.

http://www.ncbi.nlm.nih.gov/entrez/query.f...l=pubmed_docsum


3) “Congenital malformations among 911 newborns conceived after infertility treatment with letrozole or clomiphene citrate”

Study comparing the incidence of birth defects between clomid (clomiphene citrate) babies and femara (letrozole) babies. Femara had fewer! E-published May 2006.

http://www.ncbi.nlm.nih.gov/entrez/query.f...l=pubmed_docsum


4) “Effects of letrozole on superovulation with gonadotropins in women undergoing intrauterine insemination. “

Dec 2003 study comparing injectables only treatment to injectables+femara.

http://www.ncbi.nlm.nih.gov/entrez/query.f...l=pubmed_DocSum


5) “Femara Link to Birth Defects Called Incorrect “

April 2006 article that refutes the claim (from 2005 Canadian study) that femara is unsafe for ovulation induction.

http://www.medpagetoday.com/Endocrinology/...rtility/tb/3144


6) “Pregnancy outcome after the use of an aromatase inhibitor for ovarian stimulation.”

Feb 2005 study on the effectiveness of letrozole (femara) for ovulation. Favorable pregnancy outcomes with low incidences of multiples.

http://www.ncbi.nlm.nih.gov.libproxy.lib.u...l=pubmed_doc sum


7) “Use of an aromatase inhibitor for induction of ovulation in patients with an inadequate response to clomiphene citrate.”

Feb 2001 study about the effectiveness of femara in patients who did not respond to clomid. Factors were occurance of ovulation, endometrial thickness, and pregnancy rates.

http://www.ncbi.nlm.nih.gov/entrez/query.f...l=pubmed_DocSum
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  #4  
June 21st, 2007, 02:10 PM
Member
Join Date: Jun 2007
Location: SE United States
Posts: 12
Holy bajingo! How weird, to see my own post (from another BB) copied here! The information KittyMom listed is data that I compiled & posted elsewhere. I take femara, and by now have done a LOT of research on it. I welcome any questions!
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BFP 11/23/07 (16dpo) after TTC for over 3 years
EDD July 30, 2008

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  #5  
August 6th, 2008, 07:30 PM
Mega Super Mommy
Join Date: Jul 2008
Posts: 1,117
Femaras half-life is shorter than clomid. That is why some offices see it as safer. I am not taking anything but my OB said they could put me on it when I told her clomid was out of the questions because of certain side effects and the length of the half-life. Not that femara has anything better except the shorter half-life. I had read all this information after she told me the name. It is freaky even with the other studies. I don't know I probably won't take either. But GL to all of you who are taking it!!
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  #6  
September 2nd, 2008, 11:39 AM
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Join Date: May 2007
Location: North Carolina, USA
Posts: 85
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hi ladies. I am in my 2nd month taking Femara, this month at 5 mg/day. I am on CD 11 and had an u/s today to check for follicles. I have 2, one at 12.something on the right and one at 10.something on the left. I have had far fewer side-effects on the Femara than i did on the Clomid while TTC my daughter. Any advice anyone could give me would be HUGELY helpful and appreciated.

Krista
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