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`Symptoms 3: Diagnosis
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`Treatment 8: Side Effects
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`Ho me —. Treatment 3. Side Elfects —. Hormonal Therapy —. Selective Estrogen Receptor Modulators [SERMs)
`
`Tamoxifen ll'I Plll l:0ffl'I
`(Brand Name: Nolvadex)
`
`Tamoxifen in Liquid
`Form (Brand Name:
`Soltamox)
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`Evista
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`Selective Estrogen Receptor
`Modulators (SERMS)
`
`. Save as Favorite
`"‘ ".3 ‘EC? '2'? '€C3"""."3.'-.'. 3"? :Learn more:
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`Selective estrogen receptor modulators, called SERlvls for short, block the
`effects of estrogen in the breast tissue. SERNB work by sitting in the estrogen
`receptors in breast cells. If a SERM is in the estrogen receptor, there is no room
`for estrogen am it can't attach to the cell. If estrogen isn't attached to a breast
`cell, the cell doesn't receive estrogen's signals to grow and multiply.
`
`Cells in other tissues in the body, such as bones and the uterus, 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 bore cell estrogen receptors and both of those estrogen receptors
`are different from uterire 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 SERlvls:
`
`tamoxifen in pill form [also called tamoxifen citrate; brand name: Nolvadex);
`tamoxifen in Iiguid form (brand name: Soltamox)
`
`Evista [chemical name: raloxifene)
`
`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.
`
`SERlvls 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 SERlvls to aromatase inhibitors have looked at tamoxifen versus
`aromatase inhibitors. Several studies have compared tamoxifen with aromatase
`inhibitors to see which type of medicire was more effective in treating early-
`stage, hormone—receptor—positive breast cancer in postmenopausal worren.
`Based on the results, 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—receptor—
`positive breast cancer, arornatase 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 takirg tamoxifen for
`5 years continues to reduce the risk of the cancer comirg back, compared to
`no treatment after tamoxifen.
`
`Taking an aromatase inhibitor for 5 years after taking tamoxifen for 5 years
`continues to reduce tl'e risk of tie cancer comirg back, compared to no
`treatment after tamoxifen.
`
`MYLAN PHARMS. INC. EXHIBIT 1033 PAGE 1
`
`

`
`For prernenopausal women diagnosed with hormone—receptor—positive breast
`cancer, the SERM tamoxifen is the hormonal therapy treatment standard.
`
`Side effects of SERMS
`
`SERlvls may cause some serious side effects, including blood clots, stroke, and
`erdometrial cancer. If you and your doctor are considering tamoxifen or anotl'er
`SERM as part of your 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 ifyou have any of these symptoms:
`
`abnormal vaginal bleeding or discharge
`
`pain or pressure in the pelvis
`
`leg mg or tenderness
`
`chest pain
`shortness of breath
`
`weakness, tingling, or numbness in your face, arm, or leg
`
`sudden diffic um seeing
`dizziness
`
`sudden severe headache
`
`Tl'e most common side effects of SERMs are:
`
`fafgue
`hot flashes
`
`night sweats
`
`vaginal dis charg
`
`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 developirg embryos. You should use an effective non-
`hormonal type of birth control — such as condoms, a diaphragm alorg with
`spermicide, or a non—hormona| |.U.D. —while you are taking a SERM. Ask your
`doctor which type of non—hormona| 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 SERlv'|_
`
`As a benefit, SERMs also can improve bone density, which reduces the risk of
`osteoporosis.
`
`Lastmodrified on November 5, 2015 at 11:50 AM
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`MYLAN PHARMS. INC. EXHIBIT 1033 PAGE 2
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`MYLAN PHARMS. INC. EXHIBIT 1033 PAGE 3