Table of Contents
- What exactly is Femara?
- How are Femara and Letrozole Used as a Fertility Drug?
- Off-label use of Femara for infertility
- Efficacy in the treatment of infertility
- Dosage for infertility treatment
- Symptoms and Consequences
- Suggested dose and administration
- Handling and Keeping Things Safe
What exactly is Femara?
Femara is a brand-name prescription medication that has been authorized for the treatment of breast cancer in women who have completed menopause.
Femara is a medication that has been authorized for the treatment of hormone receptor-positive (HR+) breast cancer. It is believed that hormones, such as estrogen, have a role in the development and progression of this kind of breast cancer. Femara may also be used to treat some kinds of breast cancer whose hormone receptor status is not known, according to the National Cancer Institute.
Femara is a medication that is provided to women who have specific types of breast cancer, whether it is early or advanced. Cancer has not spread outside of your breast or the lymph nodes in your armpit if you are diagnosed with early-stage breast cancer. Advancement of breast cancer means that it has progressed to neighboring regions or lymph nodes (known as locally advanced breast cancer), or it has moved to distant parts of the body (known as metastatic breast cancer) (called metastatic breast cancer).
For women with early HR+ breast cancer, Femara is administered in the following ways:
Treatment as a preventative measure. Femara is used in this situation to assist reduce the chance of breast cancer recurring after it has been surgically removed.
Treatment with an adjuvant for a longer period of time Specifically for this purpose, Femara is prescribed to help reduce the chance of breast cancer recurring after it has been treated with both surgery and five years of tamoxifen (another cancer drug).
It is prescribed for advanced breast cancer that is either hormone receptor positive (HR+) or whose hormone receptor status is unknown in the following situations:
The first line of defense. Femara is the initial medicine administered to patients with advanced breast cancer who are receiving first-line therapy.
Treatment in the second or third instance. Femara is used as a second-line treatment for advanced breast cancer when other treatments have failed to control the disease. This is a situation in which Femara may be used to treat advanced breast cancer that has returned or spread after prior therapies.
Femara is a prescription medication that includes the chemical letrozole. It is a kind of hormone treatment used to treat breast cancer. These kinds of therapy work by preventing estrogen from stimulating the growth of breast cancer cells. Femara is a form of hormone treatment known as an aromatase inhibitor, and it is used to treat breast cancer. It has an effect by reducing the quantity of estrogen produced by your body.
Femara is available in the form of pills that are taken orally. There is just one dosage strength available: 2.5 mg.
How are Femara and Letrozole Used as a Fertility Drug?
Femara to Induce Ovulation
When the enzyme aromatase is blocked by the letrozole drug, estrogen levels are lowered in young women. This occurs in the brain and pituitary gland raising the release of FSH (follicle stimulating hormone) (follicle stimulating hormone).
In women who have polycystic ovarian syndrome or anovulation (a difficulty with ovulation) the rise in FSH hormone may result in growth of a mature follicle in the ovary and ovulation of an egg. Doctors term this procedure “induction of ovulation”.
Femara to Increase Pregnancy Chances in Ovulating Women
In women who already ovulate on their own, therapy with Femara may result in formation of numerous follicles and multiple eggs releasing.
Release of numerous eggs might improve the chances for conception as opposed to release of a single egg during a regular menstrual cycle
Doctors refer to the process of promoting ovulation of numerous follicles and eggs as superovulation, or managed ovarian hyperstimulation.
In women who have polycystic ovarian syndrome (PCOS) and unexplained infertility, the oral medicine Femara (letrozole) is used to induce ovulation and increase their chances of becoming pregnant. Even though Femara is a breast cancer medication that has been authorized by the U.S. Food and Drug Administration, it has been used off-label by fertility specialists since 2001 because it has less side effects than Clomid (clomiphene) and a reduced chance of multiple pregnancies.
Clomid is the current first-line treatment for infertility in women with PCOS, and it is safe and effective. Recently conducted study, on the other hand, has revealed that Femara may be associated with considerably greater rates of pregnancy in this particular group of women.
Femara is also widely used in the treatment of Clomid resistance after other treatments have failed. The occurrence of this condition happens when Clomid fails to promote ovulation for at least three treatment cycles, despite increasing doses.
Femara is being used for infertility outside of its approved indications.
In order to treat specific disorders, the Food and Drug Administration (FDA) licenses prescription medications such as Femara for use on the market. Femara, on the other hand, is occasionally prescribed for illnesses that are not included on the label. When a medicine that has been licensed to treat one ailment is used to treat another condition, this is known as off-label usage.
Off-label use of Femara for infertility
When infertility is caused by a difficulty with ovulation, it is most often utilized (the release of eggs from your ovaries). Polycystic ovarian syndrome (PCOS) is the most prevalent cause of ovulation issues that end in infertility. Femara, on the other hand, is occasionally used to treat infertility that does not seem to have a clear reason.
Femara is used to treat infertility in all of these situations by stimulating (or causing) ovulation to occur. Femara will be taken for a few days following the start of your menstruation in order to achieve this result. This has the effect of temporarily lowering your estrogen level.
This stimulates your pituitary gland to produce chemicals known as follicle-stimulating hormone (FSH) and luteinizing hormone (LH) into your body (LH). In your ovary, these hormones accelerate the maturation of an egg so that it may be released from the ovary. This is the mechanism through which Femara induces ovulation. Ovulation induction is the term used to describe this method of using the medication.
Taking Femara when you are already ovulating has the potential to induce more eggs to develop and be discharged from your ovaries than normal. Controlled ovarian hyperstimulation, also known as superovulation, is the medical term for this syndrome.
In women with PCOS, hormone issues, irregular or missing periods, and cysts on the ovaries are all symptoms of the illness. Women who have PCOS often do not ovulate as they should, making it difficult for them to get pregnant.
Efficacy in the treatment of infertility
If you are attempting to conceive (TTC), using Femara may be able to assist you in becoming pregnant via sexual contact or the use of intrauterine insemination (IUI). However, the actual success rates of Femara in terms of obtaining pregnancy and giving birth to live children are dependent on a variety of conditions. These are some examples:
what is causing your infertility, how old you are, and if you are taking Femara in conjunction with other fertility treatments
If your body is not already ovulating when you start therapy with Femara for infertility, you will have a better chance of having a successful pregnancy.
Consult the drug’s prescription material to learn more about how successful Femara was in treating infertility in clinical trials. Discuss your questions and concerns about taking Femara for infertility with your doctor if you have any at all.
Directives from a global perspective
Letrozole (the active ingredient in Femara) is recommended by Trusted Source as an effective medication for triggering ovulation.
Dosage for infertility treatment
It is recommended that you take 2.5 mg Femara once a day for 5 days in order to induce ovulation with this medication. Your doctor may instruct you to begin taking the medication on either the third or fifth day of your menstrual cycle. (The beginning day of your menstrual cycle corresponds to the first day of your menstruation. If you are not experiencing periods when you begin taking Femara, your doctor will advise you on the best time to begin taking the medication.
Some doctors may advise you to take an increased dose of Femara for a longer period of time, such as 5 mg or 7.5 mg daily for 5 days.
The maximum dosage of Femara for fertility therapy has not yet been identified, according to the latest research. One research conducted in 2011 looked at the possibility of treating infertility with dosages higher than the current therapeutic dose. More study, however, is required to determine if greater dosages of Femara are more effective than lower doses of the drug. Always remember to follow your doctor’s instructions on the dose of Femara you should take.
When taking Femara for infertility, there are several side effects to be aware of.
Side effects associated with the use of Femara for infertility include the following, which may be both minor and serious:
a feeling of exhaustion (lack of energy)
bursts of heat
soreness in the breasts
Mood swings are a common occurrence.
sweats throughout the night
spotting after vomiting (light vaginal bleeding between periods)
Ovarian cysts occur infrequently, as does ovarian hyperstimulation syndrome (OHSS), which occurs when your ovaries produce more eggs than they should.
How to use Femara for infertility treatment
After the start of your menstrual cycle, you will typically take Femara by mouth once daily for 5 days to regulate your period. It is possible that your doctor may instruct you to take Femara on cycle days 3 to 7 or cycle days 5 to 9. (The first day of your menstrual cycle corresponds to the first day of your period.) Always follow your doctor’s instructions and take Femara precisely as prescribed.
Ovulation usually occurs between 5 and 10 days after you have taken your final Femara medication, depending on your individual circumstances. When it comes to determining when you are going to ovulate, your doctor will most likely suggest that you use an ovulation predictor test.
While attempting to conceive naturally, your doctor will also advise you on the best time to begin having intercourse with your partner. You may also be advised by your doctor when you should visit the clinic for artificial insemination if you are utilizing intrauterine fertility (IUI).
Symptoms and Consequences
Letrozole works by lowering estrogen levels in the body, which helps to accelerate the ovulation process. Women might have symptoms if their estrogen levels are too low in any way. The following are the most frequently seen side effects associated with Femara use:
Vision that is hazy
Breast soreness is a common complaint.
Sleeping problems are a common occurrence.
Flashes of heat
Sweating at Night
Spots or irregular menstrual blood are signs of a problem.
Stomach aches and pains
If you develop blurred vision or any other symptoms that seem to be very serious, you should consult your doctor right once.
The risk of developing ovarian hyperstimulation syndrome (OHSS) while using Femara is low, but it may occur in some women who are taking the medication. OHSS symptoms can range from abdominal bloating and diarrhea to acute shortness of breath and chest pains.
Suggested dose and administration
It is advised that you take one 2.5 mg pill once a day, without regard to whether or not you are eating anything.
In the treatment of early breast cancer as an adjuvant therapy
The appropriate length of therapy with letrozole in the adjuvant context is not known at this time. The median treatment duration in both the adjuvant trial and the post-approval adjuvant study was 5 years in both studies. In the event of a recurrence, treatment should be terminated.
Use in the treatment of early breast cancer as an adjuvant treatment for an extended period of time
In the prolonged adjuvant scenario, it is not known what the appropriate treatment period with Femara should be. The study’s therapy was expected to last for a total of five years. The median treatment duration for Femara was 60 months, according to the final revised study, which was completed after a median follow-up of 62 months. In all, 71% of patients had prolonged adjuvant therapy for at least 3 years, with 58 percent completing at least 4.5 years of treatment. When a tumor recurs, the therapy should be stopped immediately.
Treatment of advanced breast cancer in the first and second lines of treatment
When treating individuals with advanced illnesses, it is important to keep them on Femara until tumor progression becomes visible.
In the Case of Hepatic Impairment
Patients with mild to severe hepatic impairment need not have their dose adjusted, however Femara blood concentrations were shown to be somewhat higher in people with moderate hepatic impairment owing to cirrhosis than in the general population. The dosage of Femara should be lowered by 50% in individuals with cirrhosis and severe hepatic impairment [see WARNINGS AND PRECAUTIONS for further information]. Femara is prescribed for such people at a dosage of 2.5 mg every other day, taken subcutaneously. Currently, there is little information available on the impact of hepatic impairment on Femara exposure in noncirrhotic cancer patients with increased bilirubin levels.
In the Case of Renal Impairment
If the patient’s creatinine clearance is more than or equal to 10 mL/min, there is no need to change the medication’s dose.
What dosage and forms and strengths are supplied?
Dark yellow, film-coated tablets with beveled edges that are 2.5 mg in strength. The tablets are round, somewhat biconvex, and round with beveled edges that are 2.5 mg in strength (imprinted with the letters FV on one side and CG on the other side).
Handling and Keeping Things Safe
HDPE bottles with a safety screw lid are used for packaging.
Tablets containing 2.5 mg
Bottles of 30 pills with the NDC 0078-0249-15 are available.
Maintain a temperature of 25°C (77°F); variations to 15°C to 30°C (59°F to 86°F) are acceptable [see USP Controlled Room Temperature].
There is growing evidence that Femara may be a better option for people with PCOS who are experiencing ovulation issues.
Several studies, including a 2014 research published in the New England Journal of Medicine, found that 27.5 percent of women with PCOS who used Femara were successful in having a child, compared to 19.5 percent of women who took Clomid. Advantages were discovered in a number of other areas by the same investigation.
For example, while comparing Femara to Clomid, the ovulation rate was greater with Femara (61.7 percent) (48.3 percent ). Women who were obese and had PCOS and took Femara had a greater birth rate than those who were not. The number of multiple pregnancies was lower in women who took Femara (3.2 percent) compared to those who used Clomid (5.1 percent) (7.4 percent ).
For the time being, the risk of miscarriage was almost same for the two medications (Femara 31.8 percent versus Clomid 28.2 percent ).
Similar to this, a 2015 research published in PLoS One found that there was no statistically significant difference in the overall risk of birth defect among infants born to moms who conceived naturally vs those who took Femara or Clomid throughout their pregnancy.