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`Home —- Treatment 8: Side Effects —- Hormonal Therapy — Selective Estrogen Receptor Modtilators (SERMS)
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`Tamoxifen in Pill Form
`(Brand Name: Nolvadex]
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`Soltamox)
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`|nnoPharma Exhibit 1059.0001
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`Selective Estrogen Receptor
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`Modulators (SERMSJ
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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 muitiply.
`
`Cells in other tissues in the body. such as bones and the Lnerus, 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, SERI-its 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 liguid 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 tamox ifen 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.
`
`

`

`For premenopausal women diagnosed with hormone—receptor—posi'tive 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, Q, 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:
`
`- abnormal vaginal bleeding or discharge
`
`0 pain or pressure in the pelvis
`
`-
`
`leg mg or tenderness
`
`I chest pain
`- shortness of breath
`
`- weakness, tingling, or numbness in your face. arm, or leg
`
`- sudden dirfficum seeing
`- dizziness
`
`- sudden severe headache
`
`The most common side effects of SERMs are:
`
`fatigue
`-
`- hotflashes
`
`- night sweats
`
`- vaginal discharge
`
`- mood swings
`
`You should not take a SERM ifyou are breastfeeding. pregnant. trying to get
`pregnant, or ifthere is any chance that you could be pregnant. These medicines
`may cause damage to developing embryos. You should use an effective 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 after 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_, 2915 at '."l.'5O AM
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