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`Home — Treatment 8: Side Effects — Hormonal Therapy — Selective Estrogen Receptor Modulators (SERMS)
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`(Brand Name: Nolvadex]
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`Tamoxifen in Liquid
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`Selective estrogen receptor modulators, called SERMs for short. block the
`effects of estrogen in the breast tissue. SERMs work by sitting in the estrogen
`receptors in breast cells. If a SERM is in the estrogen receptor. there is no room
`for estrogen and it can't attach to the cell. it estrogen isn't attached to a breast
`cell. the cell doesn't receive estrogen‘s signals to grow and multiply.
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`Cells in other tissues in the body. such as bones and the theme, also have
`estrogen receptors. But each estrogen receptor has a slightly different structure.
`depending on the kind of cell it is in. So breast cell estrogen receptors are
`different from bone cell estrogen receptors and both of those estrogen receptors
`are different from uterine estrogen receptors. As their name says, SERMs are
`"selective" —this means that a SERM that blocks estrogen's action in breast
`cells can activate estrogen's action in other cells, such as bone, liver, and uterine
`cells.
`
`There are three SERMs:
`
`-
`
`tamoxifen in gill form (also called tamoxifen citrate; brand name: Nolvadex};
`tamoxifen in liquid form (brand name: Soltamox)‘
`
`- Evista (chemical name: raloxifene]
`
`I Fareston (chemical name: toremifene)
`
`Each is a pill. usually taken once a day. except for tamoxifen in liquid form
`Tamoxifen is the oldest. most well-known, and most-prescribed SERM.
`
`SERMs can be used to treat women both before and after menopause.
`
`Benefits of SERMs
`
`Because tamoxifen is the most commonly used SERM. most of the studies
`comparing SERMs to aromatase inhibitors have looked at tamoxifen versus
`aromatase inhibitors. Several studies have compared tamoxifen with aromatase
`inhibitors to see which type of medicine was more effective in treating early—
`stage, hormone—receptor—positive breast cancer in postmenopausal women.
`Based on the resuits. most doctors go by the following recommendations:
`
`- An aromatase inhibitor is the best type of hormonal therapy to start with for
`postmenopausal women. When treating early stage, hormone—rec eptor—
`positive breast cancer. aromatase inhibitors have more benefits and fewer
`serious side effects than tamoxifen.
`
`- Switching to an aromatase inhibitor after taking tamoxifen for 2 to 3 years (for
`a total of 5 years of hormonal therapy) offers more benefits than 5 years of
`tamoxifen. Taking an aromatase inhibitor for 5 years after taking tamoxifen for
`5 years continues to reduce the risk of the cancer coming back. compared to
`no treatment after tamoxifen.
`
`- Taking an aromatase inhibitor for 5 years after taking tamoxifen for 5 years
`continues to reduce the risk of the cancer coming back. compared to no
`treatment after tamoxifen.
`
`InnoPharma Exhibit 1059.0001
`
`

`

`For premenopausal women diagnosed with hormone—receptor—positiye breast
`cancer. the SERM tamoxifen is the hormonal therapy treatment standard.
`
`Side effects of SERMS
`
`SERMS may cause some serious side effects, including blood clots, str_oke, and
`endometrial cancer. If you and your doctor are considering tamoxifen or another
`SERM as part ofyour treatment plan, tell your doctor ifyou smoke or have a
`history of blood clots or heart attack. If you're taking a SERM. call your doctor
`immediately if you have any of these symptoms:
`
`I abnormal vaginal bteeding or discharge
`
`I pain or pressure in the pelvis
`
`I
`
`leg mg or tenderness
`
`I chest pain
`I shortness of breath
`
`I weakness. tingling, or numbness in your face. arm. or leg
`
`I sudden difficufl seeing
`I dizziness
`
`I sudden severe headache
`
`The most common side effects of SERMs are:
`
`fatigue
`I
`I hotflashes
`
`I night sweats
`
`I vaginal discharge
`
`I mood swings
`
`You should not take a SERM ifyou are breastfeeding. pregnant. trying to get
`pregnant. or rfthere is any chance that you could be pregnant. These medicines
`may cause damage to developing embryos. You should use an etfect'rve non—
`hormonaltype of birth control -— such as condoms. a diaphragm along with
`spermicide. or a non—hormonal |.U.D. —while you are taking a SERM. Ask your
`doctor which type of non—hormonal birth control would be best for you, as well as
`how long you should use this type of birth control afler you stop taking a SERM‘.
`
`As a benefit. SERMs also can improve bone density. which reduces the risk of
`osteoporosis.
`
`Last modified on November 5‘. 2015 at 11:50 AM
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