1 CONFIRM SOMAVERT 2 START OR CONTINUE COVERAGE

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Whether you are about to start treatmentwith SOMAVERT or are continuingtreatment with new insurance coverage,the Pfizer Bridge Program is here tosupport you throughout your journey.1CONFIRM SOMAVERTCOVERAGE2START OR CONTINUESOMAVERT1APrescribed SOMAVERT2AReceiving SOMAVERT1BPfizer Bridge Program EnrollmentTAKEACTION If you are not already enrolled, you and yourTAKeACTIONdoctor will complete the Pfizer Bridge Program PatientEnrollment Form. Watch for a call from 1-800-645-1280*!A Patient Care Consultant (PCC), who is part of the PfizerBridge Program,† will contact you following your enrollment.1CKey steps to guide you on yourSOMAVERT journey:11D2B2C1EInsurance DecisionYour plan will review the information submitted by yourdoctor and approve or deny your prescription. Expect a callfrom your doctor or the PCC with the plan’s decision. ThePfizer Bridge Program can provide information on appealsrequirements should your prescription be denied.1 CONFIRM SOMAVERT COVERAGE2 START OR CONTINUE SOMAVERTThe Pfizer Bridge Program is here to help.Call the Pfizer Bridge Program at 1-800-645-1280 andselect your preferred language. Choose “2” and then“2” again for insurance or SOMAVERT Copay SupportProgram questions, or “3” for device support.3 RECEIVE ONGOING SUPPORTRefillsTAKEACTIOACTION Call your specialty pharmacy to scheduleTAKEyour next shipment one week before you expect to run outof SOMAVERT. Your PCC can assist you with coordinatingmedication shipments.Prior Authorization SubmissionPrescription drug plans (“plan”) may require your doctor toget approval or prior authorization before you can be treatedwith SOMAVERT.2Device Training and EducationYour first dose of SOMAVERT may be given by your doctor.TAKEACTIONACTION For information about receiving in-homeTAKEinjection training, contact the Pfizer Bridge Program from9 am to 7 pm Eastern Time, Monday through Friday, at1-800-645-1280 to speak with an experienced professional.Visit MySomavertTreatment.com to watch a step-by-stepinstructional video on preparing and injecting SOMAVERT.Benefits VerificationYour doctor or your PCC will confirm the acromegaly treatmentsavailable to you through your insurance and contact you to reviewthe information.3After approval from your plan, your PCC will call you to reviewyour expected out-of-pocket cost and discuss any availablefinancial assistance options. A specialty pharmacy will sendSOMAVERT directly to your home. Your PCC can share thespecialty pharmacy information with you.TAKEACTION Once you and your doctor determine thatTakeACTIONSOMAVERT is the right treatment for you, your doctor willprescribe the therapy.3RECEIVE ONGOINGSUPPORT3AQuestionsTAKEACTIONACTION Call the Pfizer Bridge Program atTAKE1-800-645-1280 if you have questions about your insurance,device, or the SOMAVERT Copay Support Program.3BReauthorizationPlans may require you to be reapproved to continueSOMAVERT treatment. Your PCC will contact you to ensurethere is no lapse in your SOMAVERT treatment.TAKEACTIONACTION Attend appointments as directed by yourTAKEdoctor to prevent any delays in reauthorization.*Note: The phone number that appears may be carrier dependent.†Certainprograms and services powered by Pfizer RxPathways .SELECTED SAFETY INFORMATIONSELECTED SAFETY INFORMATIONBlood sugar levels may go down when taking SOMAVERT. Besure to tell your doctor if you use insulin or other medicines (oralhypoglycemic medicines) for diabetes. The dose of these medicinesmay need to be reduced when you use SOMAVERT.Some people who have used SOMAVERT have developed liverproblems. These problems generally disappeared when those peoplestopped taking SOMAVERT.Please see additional Selected Safety Informationthroughout and full Prescribing Information andPatient Information in pocket.

Sign up to “Stay on Track With SOMAVERT” by visitingSOMAVERT.com to receive resources to help you betterunderstand and track your treatment journey.Insurance plans sometimes change thetreatments that are available to patientsTAKEActionACTION If your insurance changes, call your PCC atTake1-800-645-1280 as soon as possible. Your PCC can research yourinsurance coverage and provide you with information about financialassistance options, if needed and available.Financial support is available foreligible SOMAVERT patientsEligible patients pay as little as 5 for their monthly copay.Eligibility required. Annual savings up to 20,000. State andFederal Beneficiaries not eligible. Terms and conditionsapply. Please see terms and conditions in the pocket.SELECTED SAFETY INFORMATIONStop the drug right away and call your doctor if you get any of thesesymptoms: Your skin or the white part of your eyes turns yellow (jaundice) Your urine turns dark Your bowel movements (stools) turn light in color You do not feel like eating for several days You feel sick to your stomach (nausea) You have unexplained tiredness You have pain in the stomach area (abdomen)Your doctor may do blood tests before and during your treatment withSOMAVERT to check that the IGF-I levels in your blood are normal and/or that your liver is working correctly. Your dose of SOMAVERT may bechanged based on the results of these tests.If you have stopped SOMAVERT because of an allergic reaction, yourdoctor will carefully monitor what happens if you start SOMAVERTagain.TAKEACTIONACTION Contact the Pfizer Bridge Program atTAKE1-800-645-1280 to learn more about the SOMAVERTCopay Card.“There is hope and peopleto guide you on your journey.”-JeniferFor downloadable resources and to sign upfor more information, visit us at SOMAVERT.com.To hear patient stories, be sure to like us at:Facebook.com/PfizerSomavertActual acromegaly patientPATIENT INSURANCE ROADMAPYour Guide to Understanding the InsuranceProcess for SOMAVERTINDICATIONThe most common side effects with SOMAVERT are infection, pain,nausea, diarrhea, abnormal liver function tests, flu-like symptoms,and reaction at the injection site. These are not all of the possible sideeffects of SOMAVERT. For more information, speak to your doctor.SOMAVERT is a prescription medicine for acromegaly. It is for patients whosedisease has not been controlled by surgery or radiation, or patients for whomthese options are not appropriate. The goal of treatment with SOMAVERT isto have a normal IGF-I level in the blood.Inject SOMAVERT in a different place on your body each day. This canhelp prevent skin problems such as lumpiness or soreness.SELECTED SAFETY INFORMATIONSOMAVERT has not been studied in pregnant women. It is not known ifSOMAVERT passes into the mother’s milk or if it can harm the baby.Please see additional Selected Safety Information throughout andfull Prescribing Information and Patient Information in pocket.PP-SOM-USA-0642-01 2020 Pfizer Inc.All rights reserved.January 2020Do not use SOMAVERT (pegvisomant for injection) if you are allergic toSOMAVERT or anything that is in it.Be sure to tell your doctor if you use narcotic painkillers (opioid medicines)because the dose of SOMAVERT may need to be changed.Please see additional Selected Safety Informationthroughout and full Prescribing Information andPatient Information in pocket.

TERMS AND CONDITIONSBy using this co-pay card, you acknowledge that you currently meet the eligibility criteria and will comply with the terms and conditionsdescribed below: Patients are not eligible to use this card if they are enrolled in a state or federally funded insurance program, including butnot limited to Medicare, Medicaid, TRICARE, Veteran Affairs health care, a state prescription drug assistance program, or theGovernment Health Insurance Plan available in Puerto Rico (formerly known as “La Reforma de Salud”). Patient must have private insurance. Offer is not valid for cash-paying patients. Patients are responsible for as little as a 5 monthlycopayment based upon program utilization. The value of this co-pay card is limited to a maximum of 20,000 per calendar year. This co-pay card is not valid when the entire cost of your prescription drug is eligible to be reimbursed by your private insurance planor other private health or pharmacy benefit programs. You must deduct the value of this co-pay card from any reimbursement request submitted to your private insurance plan, eitherdirectly by you or on your behalf. You are responsible for reporting use of the co-pay card to any private insurer, health plan, or other third party who pays for orreimburses any part of the prescription filled using the co-pay card, as may be required. You should not use the co-pay card if yourinsurer or health plan prohibits use of manufacturer co-pay cards. You must be 18 years of age or older to redeem the co-pay card. This co-pay card is not valid where prohibited by law. Co-pay card cannot be combined with any other savings, free trial or similar offer for the specified prescription. Co-pay card will be accepted only at participating pharmacies. If your pharmacy does not participate, you may be able to submit a request for a rebate in connection with this offer. This co-pay card is not health insurance. Offer good only in the U.S. and Puerto Rico. Co-pay card is limited to 1 per person during this offering period and is not transferable. A co-pay card may not be redeemed more than once per 30 days per patient. No other purchase is necessary. No membership fee. Data related to your redemption of the co-pay card may be collected, analyzed, and shared with Pfizer, for market research and otherpurposes related to assessing Pfizer’s programs. Data shared with Pfizer will be aggregated and de-identified; it will be combinedwith data related to other co-pay card redemptions and will not identify you. Pfizer reserves the right to rescind, revoke or amend this offer without notice. Offer expires 12/31/2020.For more information, visit our website www.somavert.com, call 1-800-645-1280 or visit Pfizer.com.SOMAVERT Copay Support Program, PO Box 220746, Charlotte, NC 28222-0746PP-SOM-USA-0642-02 2020 Pfizer Inc.All rights reserved.January 2020

HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use SOMAVERT safelyand effectively. See full prescribing information for SOMAVERT.SOMAVERT (pegvisomant) for injection, for subcutaneous useInitial U.S. Approval: 2003-------------------------------------RECENT MAJOR s and Precautions DICATIONS AND USAGE------------------------------------SOMAVERT is a growth hormone receptor antagonist indicated for the treatment ofacromegaly in patients who have had an inadequate response to surgery or radiationtherapy, or for whom these therapies are not appropriate. The goal of treatment is tonormalize serum insulin-like growth factor-I (IGF-I) levels. (1)----------------------------------DOSAGE AND ADMINISTRATION-------------------------------- Administer a 40 mg loading dose subcutaneously under physician supervision. (2.1) After proper injection instruction, on day after loading dose, patients or caregiversbegin daily subcutaneous injections of 10 mg. (2.1) Adjust dosage in 5 mg increments or decrements until serum IGF-I concentrations aremaintained within age-adjusted normal range. Do not adjust dosage based on growthhormone (GH) levels or signs or symptoms of acromegaly. (2.1) Dosage range is 10 mg to 30 mg once daily. (2.1) Perform liver tests prior to first dosage and if greater than 3 times upper limit ofnormal should work-up prior to SOMAVERT administration. (2.2) Follow reconstitution and injection procedures. (2.3, 2.4)--------------------------------DOSAGE FORMS AND STRENGTHS-------------------------------For injection: 10 mg, 15 mg, 20 mg, 25 mg or 30 mg lyophilized powder in single-dosevial for reconstitution with supplied 2.25 mL syringe containing 1 mL of diluent (SterileWater for Injection) and a separate 27 gauge ½ inch safety needle. (3)FULL PRESCRIBING INFORMATION: CONTENTS*12INDICATIONS AND USAGEDOSAGE AND ADMINISTRATION2.1 Dosage Information2.2 Assess Liver Tests Prior to Initiation of SOMAVERT2.3 Loading Dose Injection Procedure2.4 Maintenance Dose Injection Procedure3DOSAGE FORMS AND STRENGTHS4CONTRAINDICATIONS5WARNINGS AND PRECAUTIONS5.1 Hypoglycemia Associated with GH Lowering in Patients with Diabetes Mellitus5.2 Liver Toxicity5.3 Cross-Reactivity with GH Assays5.4 Lipohypertrophy5.5 Systemic Hypersensitivity6ADVERSE REACTIONS6.1 Clinical Trials Experience6.2 Immunogenicity6.3 Postmarketing Experience7DRUG INTERACTIONS7.1 Insulin and/or Oral Hypoglycemic Agents7.2 OpioidsFULL PRESCRIBING INFORMATION1 INDICATIONS AND USAGESOMAVERT is indicated for the treatment of acromegaly in patients who have had aninadequate response to surgery or radiation therapy, or for whom these therapies are notappropriate. The goal of treatment is to normalize serum insulin-like growth factor-I (IGF-I)levels.2 DOSAGE AND ADMINISTRATION2.1 Dosage InformationThe recommended loading dose of SOMAVERT is 40 mg given subcutaneously, underhealthcare provider supervision. Provide proper training in subcutaneous injectiontechnique to patients or their caregivers so they can receive once daily subcutaneousinjections. On the next day following the loading dose, instruct patients or their caregiversto begin daily subcutaneous injections of 10 mg of SOMAVERT.Titrate the dosage to normalize serum IGF-I concentrations (serum IGF-I concentrationsshould be measured every four to six weeks). The dosage should not be based on growthhormone (GH) concentrations or signs and symptoms of acromegaly. It is unknown whetherpatients who remain symptomatic while achieving normalized IGF-I concentrations wouldbenefit from increased SOMAVERT dosage. Increase the dosage by 5 mg increments every 4-6 weeks if IGF-I concentrationsare elevated. Decrease the dosage by 5 mg decrements every 4-6 weeks if IGF-I concentrationsare below the normal -None. (4)----------------------------------WARNINGS AND PRECAUTIONS-------------------------------- Hypoglycemia: Monitor blood glucose in patients with diabetes mellitus and reduceanti-diabetic drug therapy as necessary. (5.1) Liver Toxicity: Should have more frequent liver tests and/or discontinue SOMAVERT.(5.2) Systemic Hypersensitivity: Monitor closely when re-initiating SOMAVERT in patientswith systemic hypersensitivity. SE t common reported adverse reactions ( 6%) are infection, pain, nausea, diarrhea,abnormal liver tests, flu syndrome, injection site reaction. (6)To report SUSPECTED ADVERSE REACTIONS, contact Pfizer, Inc. at 1-800-438-1985or FDA at 1-800-FDA-1088 or -----------DRUG INTERACTIONS-------------------------------------- Insulin and/or Oral hypoglycemic Agents: Patients with acromegaly and with diabetesmellitus may require careful monitoring and dose reductions of insulin and/or oralhypoglycemic agents. (5.2, 7.1) Opioids: Patients on opioids may need higher SOMAVERT doses to achieve appropriateIGF-I suppression. (7.2)----------------------------------USE IN SPECIFIC POPULATIONS--------------------------------Females and Males of Reproductive Potential: Advise premenopausal females of thepotential for an unintended pregnancy. (8.3)See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.Revised: 8/20198USE IN SPECIFIC POPULATIONS8.1 Pregnancy8.2 Lactation8.3 Females and Males of Reproductive Potential8.4 Pediatric Use8.5 Geriatric Use8.6 Renal Impairment10 OVERDOSAGE11 DESCRIPTION12 CLINICAL PHARMACOLOGY12.1 Mechanism of Action12.2 Pharmacodynamics12.3 Pharmacokinetics13 NONCLINICAL TOXICOLOGY13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility14 CLINICAL STUDIES16 HOW SUPPLIED/STORAGE AND HANDLING17 PATIENT COUNSELING INFORMATION*Sections or subsections omitted from the full prescribing information are not listed. IGF-I levels should also be monitored when a SOMAVERT dose given in multipleinjections is converted to a single daily injection [see Clinical Pharmacology (12)].The recommended dosage range is between 10 mg to 30 mg given subcutaneously oncedaily and the maximum daily dosage is 30 mg given subcutaneously once daily.2.2 Assess Liver Tests Prior to Initiation of SOMAVERTPrior to the start of SOMAVERT, patients should have an assessment of baseline levels ofliver tests [serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), serumtotal bilirubin (TBIL), and alkaline phosphatase (ALP)]. For recommendations regardinginitiation of SOMAVERT based on baseline liver tests and recommendations for monitoringof liver tests while on SOMAVERT, refer to Table 1 in Warning and Precautions (5.2).2.3 Loading Dose Injection ProcedureThe following instructions are for the healthcare provider to reconstitute and prepare the40 mg loading dose. The healthcare provider will need to reconstitute 2 vials of lyophilizedpowder of SOMAVERT each containing 20 mg of pegvisomant with supplied diluent [twovials of lyophilized powder and two 2.25 mL syringes containing diluent (Sterile Water forInjection) will be needed for the 40 mg loading dose]. The healthcare provider will alsoneed to inject the reconstituted SOMAVERT solution twice into the patient’s upper arm,upper thigh, abdomen, or buttocks (each injection in a different area).(a) Before administering the loading dose, remove the first package (1 vial of lyophilizedpowder of SOMAVERT containing 20 mg of pegvisomant and one 2.25 mL syringecontaining the diluent) from the refrigerator about 10 minutes prior to the plannedinjection time.

(b) Reconstitute the first 20 mg vial of lyophilized powder of SOMAVERT containing20 mg of pegvisomant with diluent. When using the diluent in the 2.25 mL syringe,inject the contents of the syringe slowly onto the sides of the vial containinglyophilized powder of SOMAVERT. Do not inject the diluent directly on the powder.(c) Do not invert the vial or shake the solution as this may cause denaturation of thepegvisomant protein. Slowly swirl the solution to ensure that all of the lyophilizedpowder has gone into solution. If foaming of the reconstituted SOMAVERT solutionis seen, the solution is likely damaged and therefore inappropriate to inject.(d) Visually inspect the reconstituted SOMAVERT solution for particulate matter anddiscoloration prior to administration. The reconstituted solution should be clear. Ifthe solution is cloudy, do not use it. Once reconstituted, the solution will contain20 mg of pegvisomant in 1 mL of solution.(e) Withdraw the 1 mL reconstituted SOMAVERT solution. The solution must beadministered within 6 hours of reconstitution.(f) Inject the first reconstituted SOMAVERT solution (20 mg/mL) subcutaneously intothe patient’s upper arm, upper thigh, abdomen, or buttocks using a 90-degreeangle.(g) Repeat steps (a) to (e) to reconstitute the second SOMAVERT dose of 20 mg.(h) Finally, inject the second reconstituted SOMAVERT solution (20 mg/mLsubcutaneously into the patient’s upper arm, upper thigh, abdomen, or buttocksusing a 90-degree angle (different area than the first injection).2.4 Maintenance Dose Injection ProcedureFor patient or caregiver instructions for reconstitution and administration of daily doses(10 mg to 30 mg), see the Patient’s Instructions for Use.a) Before administering the dose, remove one package (1 vial of lyophilized powderof SOMAVERT containing 10 mg, 15 mg, 20 mg, 25 mg or 30 mg of pegvisomantand one 2.25 mL syringe containing the diluent) from the refrigerator about10 minutes prior to the planned injection time.b) Reconstitute the lyophilized powder of SOMAVERT with diluent. When using thediluent in the 2.25 mL syringe, inject the contents of the syringe slowly onto thesides of the vial containing lyophilized powder of SOMAVERT. Do not inject thediluent directly on the powder.c) Do not invert the vial or shake the solution as this may cause denaturation of thepegvisomant protein. Slowly swirl the solution to ensure that all of the lyophilizedpowder has gone into solution. If foaming of the reconstituted SOMAVERTsolution is seen, the solution is likely damaged and therefore inappropriate toinject.d) Visually inspect the reconstituted SOMAVERT solution for particulate matterand discoloration prior to administration. The reconstituted solution should beclear. If the solution is cloudy, do not use it. Once reconstituted, the solutionwill contain 10 mg, 15 mg, 20 mg, 25 mg or 30 mg of pegvisomant in 1 mLof solution.e) Withdraw the 1 mL reconstituted SOMAVERT solution. The solution must beadministered within 6 hours of reconstitution.f) Inject the reconstituted SOMAVERT solution subcutaneously into the upper arm,upper thigh, abdomen, or buttocks using a 90-degree angle.3 DOSAGE FORMS AND STRENGTHSFor injection: 10 mg, 15 mg, 20 mg, 25 mg or 30 mg white lyophilized powder insingle-dose vial for reconstitution with supplied 2.25 mL syringe containing 1 mL of diluent(Sterile Water for Injection) and a separate 27 gauge ½ inch safety needle.4 CONTRAINDICATIONSNone.5 WARNINGS AND PRECAUTIONS5.1 Hypoglycemia Associated with GH Lowering in Patients with Diabetes MellitusGH opposes the effects of insulin on carbohydrate metabolism by decreasing insulinsensitivity; thus, glucose tolerance may improve in some patients treated with SOMAVERT.Patients should be carefully monitored and doses of anti-diabetic drugs reduced asnecessary to avoid hypoglycemia in patients with diabetes mellitus.5.2 Liver ToxicityBaseline serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), serumtotal bilirubin (TBIL), and alkaline phosphatase (ALP) levels should be obtained prior toinitiating therapy with SOMAVERT. Table 1 lists recommendations regarding initiation oftreatment with SOMAVERT, based on the results of these liver tests (LTs).Asymptomatic, transient elevations in transaminases up to 15 times ULN have beenobserved in 2% of subjects among two open-label trials (with a total of 147 patients).These reports were not associated with an increase in bilirubin. Transaminase elevationsnormalized with time, most often after suspending treatment. Postmarketing reports haveidentified elevations in serum hepatic transaminases up to greater than 20 times ULNassociated with elevation in total bilirubin greater than 2 times ULN. In many of thesecases, discontinuation of SOMAVERT therapy resulted in improvement or resolution ofhepatic laboratory abnormalities.SOMAVERT should be used in accordance with the information presented in Table 2 withrespect to liver test abnormalities while on SOMAVERT treatment.Table 1. Recommendations of Initiating SOMAVERT Based on Baseline LTs and PeriodicMonitoring of LTs During SOMAVERT TreatmentBaseline LT LevelsRecommendationsNormal May treat with SOMAVERT. Monitor LTs at monthly intervals during the first 6 months oftreatment, quarterly for the next 6 months and then bi-annuallyfor the next year.Elevated, but lessthan or equal to3 times ULNMay treat with SOMAVERT; however, monitor LTs monthly forat least one year after initiation of therapy and then bi-annually forthe next year.Greater than3 times ULN Do not treat with SOMAVERT until a comprehensive workupestablishes the cause of the patient’s liver dysfunction. Determine if cholelithiasis or choledocholithiasis is present,particularly in patients with a history of prior therapy withsomatostatin analogs. Based on the workup, consider initiation of therapy withSOMAVERT. If the decision is to treat, LTs and clinical symptoms should bemonitored very closely.If a patient develops LT elevations, or any other signs or symptoms of liver dysfunctionwhile receiving SOMAVERT, the following patient management is recommended (Table 2).Table 2. Clinical Recommendations Based on Liver Test Results While on SOMAVERTLT Levels and ClinicalSigns/SymptomsRecommendationsGreater than or equal to 3 but less than5 times ULN (without signs/symptomsof hepatitis or other liver injury, orincrease in serum TBIL) May continue therapy with SOMAVERT.However, monitor LTs weekly todetermine if further increases occur (seebelow). Perform a comprehensive hepatic workupto discern if an alternative cause of liverdysfunction is present.At least 5 times ULN, or transaminaseelevations at least 3 times ULNassociated with any increase in serumTBIL (with or without signs/symptomsof hepatitis or other liver injury) Discontinue SOMAVERT immediately. Perform a comprehensive hepaticworkup, including serial LTs, to determineif and when serum levels return tonormal. If LTs normalize (regardless of whether analternative cause of the liver dysfunctionis discovered), consider cautious reinitiation of therapy with SOMAVERT, withfrequent LT monitoring.Signs or symptoms suggestive ofhepatitis or other liver injury (e.g.,jaundice, bilirubinuria, fatigue, nausea,vomiting, right upper quadrant pain,ascites, unexplained edema, easybruisability) Immediately perform a comprehensivehepatic workup. If liver injury is confirmed, the drugshould be discontinued.5.3 Cross-Reactivity with GH AssaysSOMAVERT has significant structural similarity to growth hormone (GH) which causesit to cross-react in commercially available GH assays. Since serum concentrations oftherapeutically effective doses of SOMAVERT are generally 100 to 1000 times higher thanthe actual serum GH concentrations seen in patients with acromegaly, measurements ofserum GH concentrations will appear falsely elevated.5.4 LipohypertrophyThere have been cases of lipohypertrophy in patients treated with SOMAVERT. In a doubleblind, 12-week, placebo-controlled study, there was one case (1.3%) of injection sitelipohypertrophy reported in a subject receiving 10 mg/day. The subject recovered whileon treatment. Among two open-label trials (with a total of 147 patients), there were twosubjects, both receiving 10 mg/day, who developed lipohypertrophy. One case recoveredwhile on treatment, and one case resulted in a discontinuation of treatment. Injectionsites should be rotated daily to help prevent lipohypertrophy (different area than thelast injection).5.5 Systemic HypersensitivityIn subjects with systemic hypersensitivity reactions, caution and close monitoring shouldbe exercised when re-initiating SOMAVERT therapy [see Adverse Reactions (6.3)].6 ADVERSE REACTIONSClinically significant adverse reactions that appear in other section of the labeling include: Hypoglycemia Associated with GH Lowering in Patients with Diabetes Mellitus [seeWarnings and Precautions (5.1)] Liver Toxicity [see Warnings and Precautions (5.2)] Cross-Reactivity with GH Assays [see Warnings and Precautions (5.3)] Lipohypertrophy [see Warnings and Precautions (5.4)] Systemic Hypersensitivity [see Warnings and Precautions (5.5)]Elevations of serum concentrations of ALT and AST greater than ten times the ULN werereported in two patients (0.8%) exposed to SOMAVERT in pre-approval clinical studies. Onepatient was rechallenged with SOMAVERT, and the recurrence of elevated transaminaselevels suggested a probable causal relationship between administration of the drug and the

elevation in liver enzymes. A liver biopsy performed on the second patient was consistentwith chronic hepatitis of unknown etiology. In both patients, the transaminase elevationsnormalized after discontinuation of the drug.Elevations in ALT and AST levels were not associated with increased levels of TBIL andALP, with the exception of two patients with minimal associated increases in ALP levels(i.e., less than 3 times ULN). The transaminase elevations did not appear to be related tothe dose of SOMAVERT administered, generally occurred within 4 to 12 weeks of initiationof therapy, and were not associated with any identifiable biochemical, phenotypic, orgenetic predictors.6.1 Clinical Trials ExperienceBecause clinical trials are conducted under widely varying conditions, adverse reactionrates observed in the clinical trials of a drug cannot be directly compared to rates in theclinical trials of another drug and may not reflect the rates observed in practice.In a 12-week randomized, placebo-controlled, double-blind, fixed-dose study ofSOMAVERT in subjects with acromegaly, 32 subjects received placebo and 80 subjectsreceived SOMAVERT once daily [see Clinical Studies (14)]. A total of 108 subjects(30 placebo, 78 Somavert) completed 12 weeks of study treatment.Overall, eight patients with acromegaly (5.3%) withdrew from pre-marketing clinicalstudies because of adverse events, including two patients with marked transaminaseelevations, one patient with lipohypertrophy at the injection sites, and one patient withsubstantial weight gain. Most adverse events did not appear to be dose-dependent.Table 3 shows the incidence of adverse events that were reported in at least two patientstreated with SOMAVERT and at frequencies greater than placebo during the 12-week,placebo-controlled study.Table 3. Adverse Reactions in a 12-week Placebo-Controlled Study in Patients withAcromegaly*Placebon 32Infection†PainNauseaDiarrheaAbnormal liver function testsFlu syndromeInjection site reactionDizzinessAccidental injuryBack painSinusitisChest painPeripheral edemaHypertensionParesthesia2 (6%)2 (6%)1 (3%)1 (3%)1 (3%)002 (6%)1 (3%)1 (3%)1 (3%)0002 (6%)10 mg/dayn 266 (23%)2 (8%)01 (4%)3 (12%)1 (4%)2 (8%)2 (8%)2 (8%)2 (8%)2 (8%)1 (4%)2 (8%)00SOMAVERT15 mg/dayn 2601 (4%)2 (8%)01 (4%)3 (12%)1 (4%)1 (4%)1 (4%)002 (8%)02 (8%)020 mg/dayN 2804 (14%)4 (14%)4 (14%)1 (4%)2 (7%)3 (11%)1 (4%)01 (4%)1 (4%)01 (4%)02 (7%)* Table includes only those events that were reported in at least 2 patients and at a higher incidence inpatients treated with SOMAVERT than in patients treated with placebo.†The 6 events coded as “infection” in the g

Enrollment Form. Watch for a call from 1-800-645-1280*! . †Certain programs and services powered by Pfizer RxPathways . Pfizer reserves the right to rescind, revoke or amend this offer without notice. Offer expires 12/31/2020. For more information, visit our website www.somavert.com, call

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