VIEKIRA PAK® and VIEKIRA PAK-RBV® paritaprevir/ritonavir/ombitasvir + dasabuvir +/- ribavirin Quality Use of Medicines This slide set is intended to be read as a whole without modification. AbbVie Limited (New Zealand) does not endorse the use of unregistered products or products outside of their registered indications. This activity is supported by AbbVie Limited. Please refer to the Data Sheet for licensed indications. This can be accessed at www.medsafe.govt.nz, www.viekira.co.nz, through your AbbVie representative or through AbbVie Medical Information on 0800 900 030. AbbVie Limited, Wellington, New Zealand. Learning Objectives to support quality use of medicine (QUM) Upon completion of the module, participants should be able to: 1. Describe VIEKIRA PAK and VIEKIRA PAK-RBV’s: 1. 2. 3. 4. 5. 6. 7. 8. Indication, mechanism of action and efficacy Packaging, and recommended dosing regimen Contraindications, precautions Ribavirin dose and monitoring Use in pregnancy and breastfeeding Safety profile and common adverse events Mechanism of drug-drug interactions The process for reporting adverse events 2. Identify tools and resources which can be used to support the management of any identified drug - drug interactions, contraindications and precautions, and liaise with the relevant prescriber if necessary. 3. Understand the resources available to support patients with hepatitis C treated with VIEKIRA PAK or VIEKIRA PAK-RBV. Glossary AE Adverse event ALT Alanine aminotransferase (a liver enzyme) Asthenia Lack or loss of strength and energy Compensated cirrhosis Scarring of the liver causing mild liver impairment (Child Pugh A) HCV Hepatitis C virus NZSG New Zealand Society of Gastroenterology PegIFN/RBV Pegylated interferon with ribavirin Prior null response No response to prior antiviral treatment with peginterferon/ribavirin RBV Ribavirin SAE Serious adverse event SVR Sustained virologic response defined as undetectable HCV RNA SVR12/Cure SVR 12 weeks after the last dose of treatment. Patients who achieve SVR12 can be said to have achieved cure Overview of Content • • • Information about the AbbVie Care Pharmacy programme, including Xpharm logistics for supply Hepatitis C in NZ – key facts VIEKIRA PAK & VIEKIRA PAK-RBV (VIEKIRA PAK with ribavirin) – – – – – – – – – • Indication, mechanism of action and efficacy Packaging and recommended dosing regimen Contraindications, precautions Ribavirin dose and monitoring Use in pregnancy and breastfeeding Safety profile and common side effects Drug-drug interactions Tools and resources to support the management of drug-drug interactions Reporting of adverse events to AbbVie AbbVie Care Pharmacy Programme next steps Information on the AbbVie Care Pharmacy Programme • This VIEKIRA PAK and VIEKIRA PAK-RBV QUM (Quality of Use Medicine) module is designed to support Pharmacists who wish to register with AbbVie to become an AbbVie Care Pharmacy. • The distribution mechanism for Hepatitis C medicines is similar to that used by PHARMAC for a number of other high-cost funded medicines. Under this Xpharm mechanism, the pharmacy does NOT purchase the medicine and pharmacies cannot claim a dispensing fee. • The AbbVie Care Pharmacy Programme is sponsored by AbbVie Limited, the manufacturer of VIEKIRA PAK and VIEKIRA PAK-RBV. Information on the AbbVie Care Pharmacy Programme continued.. • Only pharmacies enrolled in the AbbVie Care Pharmacy Programme can dispense the medicine. • There is a one-off payment of a fee-for-service of NZ$100 per patient for the 3 months of dispensing provided (or if a patient is on a longer treatment course the Pharmacy is paid a fee-for-service of NZ$200). • Payment will be made to the AbbVie Care pharmacy by Healthcare Logistics (HCL). The patient does NOT pay for any pharmacy charges associated with accessing the medicine. Programme Overview Prescriber Prescriber & Patient Prescriber Writes prescription for patient Select a convenient AbbVie Care Pharmacy (list available on the online PHARMAC application form, or from www.viekira.co.nz/locations or www.pharmac.govt.nz/hepatitis-c-treatments). Completes the PHARMAC Distribution Request Form, including delivery details for the selected AbbVie Care Pharmacy. Submits/sends completed PHARMAC Distribution Request Form to PHARMAC. Provides prescription and details of the selected AbbVie Care Pharmacy to the patient. Informs patient that the pharmacy will contact them when their medication is ready for collection (up to 7-10 days from when the form is sent to PHARMAC). Sends Pharmacy delivery details to AbbVie Distributor. PHARMAC Informs Pharmacy of upcoming patients and their contact phone numbers, ahead of medicine arriving, either by email (if prescriber completes the PHARMAC form online) or by summary fax. Programme Overview Distributor AbbVie Care Pharmacist Sends entire course of medicine and Patient Resources to the selected AbbVie Care Pharmacy. Advises the patient that their medicine has arrived and reminds the patient to bring in their prescription. Takes their prescription to the selected AbbVie Care Pharmacy. Patient AbbVie Care Pharmacist Receives relevant dispensing and information about the medication from the AbbVie Care Pharmacist when collecting their medicines each month. Provides relevant information about the medication to the patient. Informs patient that all repeats must be collected from the same pharmacy. Each delivery of VIEKIRA PAK is accompanied by a patient information booklet and dosage card • For any queries regarding product supply and/or the information resources as shown, please contact HCL (Healthcare Logistics) directly - details below Customer Service | Healthcare Logistics Reception +64 9 918 5100 | Ext 8022 | • For any PHARMAC related queries: Hepatitis C Coordinator on 0800 023 588 (option 3) or [email protected] • For medical information or matters relating to VIEKIRA PAK/VIEKIRA PAK-RBV Contact [email protected] or phone 0800 900 030 Monthly Dispensing – suggestions on best practice activities to support your HCV patients • Before the first dispensing, phone the patient to advise them that their medicine has arrived and make a time to pick up the medication. It will not cost the patient anything to collect their VIEKIRA PAK / VIEKIRA PAK-RBV. Remind the patient to bring in their prescription. • Explain the medicine packaging: four weekly packs inside the monthly carton, 7 days of medication in each weekly pack +/- a bottle of ribavirin (RBV) tablets. • Answer any questions the patient might have about the patient booklet or dosage card. • Complete a medication history to check drug-drug interactions OR ask the patient if there have been any changes in medications since the last dispensing. Monthly Dispensing – suggestions on best practice activities to support your HCV patients continued… • Use the Data Sheets and University of Liverpool Hepatitis C drug interactions website (www.hep-druginteractions.org) to support your patient discussions. There is also a Liverpool HEP iChart app available from the website for use on smartphones and iPads. • If relevant, liaise with the patient’s local community pharmacy to support their treatment as required. • Support the patient if they have had a change in their ribavirin dosing. • Ask the patient to return any unused VIEKIRA PAK or ribavirin to your pharmacy. Hepatitis C in New Zealand • About 50,000 people have chronic hepatitis C; average age is 42-47 years • Only about 25,000 know that they have it (~ 50% diagnosis rate) • There are about 1000 new infections each year • Main risk factors for HCV infection in NZ include: • Transmission through blood products pre-1992 • Transmission through injecting drug use • There are 6 genotypes (GT1-6) • Genotype 1 is the most common at 56% There are 2 sub-types: VIEKIRA PAK and VIEKIRA PAK-RBV are indicated in genotype 1 GT1a GT1b 56% • Genotype 1a : 80% GT3a • Genotype 1b: 20% GT 2a & 2c GT4 GT6 Gane13NZ Med J 2014; 127(1407):61-74. VIEKIRA PAK & VIEKIRA PAK-RBV – – – – – – – – Indication, mechanism of action and efficacy Packaging and recommended dosing regimen Contraindications, precautions Ribavirin dose and monitoring Use in pregnancy and breastfeeding Safety profile and common side effects Drug-drug interactions, Tools and resources to support the management of drug-drug interactions – Reporting of adverse events to AbbVie Indication and mechanism of action Treatment of genotype 1 chronic hepatitis C, including patients with compensated cirrhosis, HIV-1 co-infection, and liver transplant recipients. • Paritaprevir, ombitasvir and dasabuvir are direct-acting antivirals that target different stages of the hepatitis C lifecycle • Ritonavir is included to boost the systemic exposure of paritaprevir • Ribavirin is included in some patient populations to increase the rate of sustained virologic response (SVR) AbbVie Limited. VIEKIRA PAK and VIEKIRA PAK-RBV Data Sheets. Medsafe New Zealand; Dec 2016. Daily blister pack, weekly pack and monthly carton, with or without ribavirin tabs Monthly carton Weekly pack Each weekly pack contains seven daily blister packs. Daily blister pack Ribavirin 200mg (168 tablets) VIEKIRA PAK Monthly carton Dimensions of 28-day pack: 197.75 mm x 132 mm x 133 mm VIEKIRA PAK-RBV Monthly carton Dimensions of 28-day pack, with RBV: 253.50mm x 132mm x 130mm Storage: Below 25oC AbbVie Limited. VIEKIRA PAK and VIEKIRA PAK-RBV Data Sheets. Medsafe New Zealand; Dec 2016. VIEKIRA PAK tablets and ribavirin are taken twice a day with food to increase absorption VIEKIRA PAK is taken with food (without regard to fat or calorie content), as three tablets in the morning and one in the evening. Tablets should be swallowed whole. Co-formulated paritaprevir/ritonavir (PTV/r) 75 mg/50 mg plus ombitasvir (OBV) 12.5 mg pink tablets (AV1) Dasabuvir (DSV) 250 mg beige tablets (AV2) RIBAVIRIN is taken with food, and the daily dose is given in 2 divided doses at the same times as VIEKIRA PAK. Ribavirin, 200mg tablets (weight-based dosing) Example: 1000 mg RBV dose (patient ≤ 75kg) The starting dose for ribavirin is usually based on a person’s weight: 1200 mg daily if >75kg and 1000 mg daily if ≤ 75kg; given in divided doses twice daily. Starting dose may be reduced (e.g. in renal impairment) or dose may be adjusted on treatment (e.g. in anaemia). AbbVie Limited. VIEKIRA PAK and VIEKIRA PAK-RBV Data Sheets. Medsafe New Zealand; Dec 2016. Recommended treatment regimen and duration Patient Population Treatment Duration Weight-based ribavirin daily dose <75kg = 1000mg GT1a VIEKIRA PAK-RBV† 12 weeks‡ ≥75kg = 1200mg Ribavirin is to be taken in two divided doses, morning and evening. GT1b VIEKIRA PAK 12 weeks N/A † For treatment-naïve patients with GT1a HCV without cirrhosis, VIEKIRA PAK without ribavirin can be considered as a therapeutic option. † VIEKIRA PAK-RBV is recommended in patients with an unknown subtype or with a mixed GT1 infection. ‡ 24 weeks of VIEKIRA PAK-RBV is recommended for GT1a patients with compensated cirrhosis and a prior null response to PegIFN/RBV. AbbVie Limited. VIEKIRA PAK and VIEKIRA PAK-RBV Data Sheets. Medsafe New Zealand; Dec 2016. High cure* rates (SVR12) with the approved dosing regimen Overall cure* rate was 97% (n=1055/1088). Cure* rates with the NZ approved regimen; pooled SVR12 results from Phase III trials (n=1088) GT1a % (n) VIEKIRA PAK-RBV CURE* RATES (SVR12) GT1b % (n) VIEKIRA PAK No cirrhosis Cirrhosis No cirrhosis Cirrhosis 12 weeks 12 weeks‡ 12 weeks 12 weeks 96% 93% 100% 100% (569/593) (125/134)‡ (301/301) (60/60) ‡ GT1a patients with compensated cirrhosis and a prior null response to PegIFN/RBV received 24 weeks of therapy. * Cure is defined as undetectable HCV RNA 12 weeks after the end-of-treatment (SVR12). AbbVie Limited. VIEKIRA PAK and VIEKIRA PAK-RBV Data Sheets. Medsafe New Zealand; Dec 2016. A dosing card is completed, with the dose of ribavirin tablets (as appropriate), and given to the patient with each dispensing • Complete the section of the dosage card with the dose of ribavirin (for patients on VIEKIRA PAK-RBV). • Ask the patient to make a note of how many VIEKIRA PAK tablets and ribavirin tablets they have left when they come to collect their repeat script. This will allow you to assess their adherence and reinforce its importance to provide the best chance of achieving a cure (SVR12). While the patient will have unused ribavirin tablets each month if the daily dose is <1,200 mg, any leftover VIEKIRA PAK should prompt a discussion on adherence. • Any unused medicine should be returned to the pharmacy for safe disposal. Missed Doses – advice for patients Missed dose of PTV/r/OBV* (OD dosing) • ≤12 hours: take the prescribed dose • >12 hours: do NOT take the missed dose; take the next dose as usual, with food Missed dose of DSV** (BD Dosing) • ≤6 hours: take the prescribed dose • >6 hours: do NOT take the missed dose; take the next dose as usual, with food Missed dose of RBV (BD Dosing) • Do NOT take the missed dose; take the next dose as usual, with food Patients should not take more than their prescribed dose of VIEKIRA PAK or VIEKIRA PAK-RBV to make up a missed dose^ ^A missed dose should be reported as an adverse event; see slide 40 for how to report an AE. . *PTV/r/OBV = co-formulated paritaprevir/ritonavir/ombitasvir: **DSV = dasabuvir AbbVie Limited. VIEKIRA PAK and VIEKIRA PAK-RBV Data Sheets. Medsafe New Zealand; Dec 2016. Contraindications for VIEKIRA PAK • Severe hepatic impairment (Child-Pugh C) • Co-administration with drugs that are highly dependent on CYP3A for hepatic clearance, are moderate or strong inducers of CYP3A, or are strong inducers or inhibitors of CYP2C8* • Hypersensitivity to components or excipients Additional contraindications for VIEKIRA PAK-RBV • Pregnancy (including men whose partners are pregnant). [Category X] Use two forms of contraception to avoid pregnancy, and for 6 months after ribavirin is discontinued • History of severe, unstable, or uncontrolled cardiac disease in previous 6 months • Haemoglobinopathies (e.g. thalassaemia, sickle-cell anaemia) * For info on DDIs, refer to the Data Sheets and www.hep-druginteractions.org; also see slide 31-32. AbbVie Limited. VIEKIRA PAK and VIEKIRA PAK-RBV Data Sheets. Medsafe New Zealand; Dec 2016. Precautions for VIEKIRA PAK • Not recommended for HCV genotypes other than 1 • Not recommended in patients with Child-Pugh B hepatic impairment • Not recommended for co-administration with other HCV antivirals, or for patients who have previously failed therapy with direct-acting antiviral agents • Safety & effectiveness in children younger than 18 and patients over 70 years of age have not been established. • All patients should be tested for hepatitis B virus (HBV). People with a current or previous HCV/HBV co-infection should be monitored for reactivation of HBV during or after treatment for HCV. Concomitant therapy for hepatitis B may be required. AbbVie Limited. VIEKIRA PAK and VIEKIRA PAK-RBV Data Sheets. Medsafe New Zealand; Dec 2016. Additional precautions for VIEKIRA PAK-RBV • Use with caution and close monitoring in patients with pre-existing cardiac disease or significant vascular disease (symptomatic ischaemic heart disease, recent transient ischaemic attack , cerebrovascular accident, claudication); discontinue if cardiac function deteriorates • Ribavirin (RBV) can cause dose-related haemolysis and anaemia; haemoglobin should be monitored and dose of RBV adjusted or discontinued as required (see next slide) • Discontinue RBV in case of an acute hypersensitivity reaction (e.g. urticaria, angioedema, bronchoconstriction, or anaphylaxis) • Reduce starting doses of RBV in patients with renal impairment* • ribavirin and its metabolites are excreted renally • If creatinine clearance ≤50 mL/min, RBV should only be used if considered essential; haemoglobin should be monitored intensively during treatment. * Note: It is not necessary to adjust the dose of VIEKIRA PAK in patients with mild, moderate or severe renal impairment. VIEKIRA PAK and VIEKIRA PAK-RBV Data Sheets. Medsafe New Zealand; Dec 2016. Gane, Stedman. NZ Society of Gastroenterology HCV Treatment Guidelines. 2016. Available at: www.nzsg.org.nz/cms2/uploads/2017/NZSG%20Hepatitis%20C%20Guidance_November%20UPDATE.pdf Safety monitoring: Dose reduction of ribavirin for anaemia during treatment Laboratory values Patients with no cardiac disease Patients with history of stable cardiac disease Reduce ribavirin dose to 600mg/day* if: Discontinue† ribavirin if: Haemoglobin < 100 g/l Haemoglobin < 85 g/l >20 g/L decrease in haemoglobin during any 4week period during treatment (permanent dose reduction) Haemoglobin <120 g/L despite 4 weeks at reduced dose * Patients whose dose of ribavirin is reduced to 600 mg daily should receive one 200mg tablet in the morning and two 200mg tablets in the evening. † If the abnormality is reversed, ribavirin may be restarted at 600 mg daily, and further increased to 800 mg at the discretion of the treating physician. However, a return to higher doses is not recommended. • In phase 3 clinical trials with VIEKIRA PAK-RBV, 8.5% of patients required ribavirin dose reduction. Dose reduction did not affect efficacy. AbbVie Limited. VIEKIRA PAK and VIEKIRA PAK-RBV Data Sheets. Medsafe New Zealand; Dec 2016. Pregnancy, contraception and breastfeeding • VIEKIRA PAK is not recommended (Category B3); there is no safety data for use during pregnancy or lactation • VIEKIRA PAK-RBV is contraindicated, including in men whose partners are pregnant; ribavirin is teratogenic (Category X) • Patients should be counselled on the importance of avoiding pregnancy during treatment. Reliable contraception is considered essential for women, and for men whose partners could fall pregnant. Additionally, for those receiving ribavirin (VIEKIRA PAK-RBV), two forms of contraception should be used (including a barrier method) to avoid pregnancy, during treatment and for 6 months after treatment has finished • Check for DDIs that may affect contraception efficacy • Contraceptives containing ethinylestradiol should be avoided because of possible hepatotoxicity (elevation of ALT) with VIEKIRA PAK. Women taking ethinylestradiolcontaining contraceptives should be switched to other effective contraceptives ≥2 weeks prior to starting VIEKIRA PAK until ≥2 weeks after finishing treatment • Pharmacy staff of child-bearing age should use caution when handling ribavirin • Because of the potential for adverse events in nursing infants, breastfeeding must be discontinued prior to initiation of treatment. AbbVie Limited. VIEKIRA PAK and VIEKIRA PAK-RBV Data Sheets. Medsafe New Zealand; Dec 2016. Gane, Stedman. NZ Society of Gastroenterology HCV Treatment Guidelines. 2016. Available at: www.nzsg.org.nz/cms2/uploads/2017/NZSG%20Hepatitis%20C%20Guidance_November%20UPDATE.pdf . Safety and tolerability Overall, adverse events were frequent, but generally mild (grade 1) and manageable. The most common adverse events in clinical trials: VIEKIRA PAK: fatigue, nausea, pruritis, and insomnia and asthenia. VIEKIRA PAK-RBV: as above. Patients also reported anaemia, diarrhoea, vomiting, decreased appetite, dizziness, headache, sleep disorder, cough, dyspnoea, dry skin and rash. Non-cirrhotic patients • Rates of serious adverse events were very low, with fewer than 1% discontinuations overall (similar to placebo). Cirrhotic patients • • VIEKIRA PAK-RBV: Serious adverse events occurred in 4.5% of patients and 2% discontinued due to an adverse event. VIEKIRA PAK: Serious adverse events occurred in 2% of patients. No patient discontinued due to an adverse event. AbbVie Limited. VIEKIRA PAK and VIEKIRA PAK-RBV Data Sheets. Medsafe New Zealand; Dec 2016. Poordad F et al. N Engl J Med 2014;370:1973-82 Likelihood of experiencing common side effects AbbVie Limited. VIEKIRA PAK and VIEKIRA PAK-RBV Data Sheets. Medsafe New Zealand; Dec 2016. Suggestions for management of adverse events and comorbidities can be found in the NZSG Guidelines Common adverse events • Fatigue: Check haemoglobin level and adjust ribavirin dosage accordingly. • Insomnia: Consider advice on improved sleep hygiene. If severe, then consider using zopiclone 3.75 mg nocte OR temazepam 10 mg nocte. • Nausea: Consider ondansetron at the standard recommended dosage. • Skin rash: Use 10% urea cream or fatty cream. Consult DermNet NZ at www.dermnetnz.org Comorbidities • Depression: Citalopram or escitalopram are allowed. Reporting of adverse events: see slides 40. Gane, Stedman. NZ Society of Gastroenterology HCV Treatment Guidelines. 2016. Available at: www.nzsg.org.nz/cms2/uploads/2017/NZSG%20Hepatitis%20C%20Guidance_November%20UPDATE.pdf Overview: Drug–drug interactions • All direct-acting antivirals interact with drug metabolising enzymes or transporters. Ribavirin is associated with additional drug interactions. • VIEKIRA PAK undergoes hepatic metabolism. Interactions are primarily mediated through CYP3A and P-glycoprotein inhibition. • All patients with hepatitis C should undergo a careful medicines review before treatment. • Many drug interactions are not clinically relevant, or can be managed by monitoring and /or dose adjustment. Others are contraindicated, and should be stopped or switched to alternatives. • No dose adjustment is needed for VIEKIRA PAK itself. • During each patient dispensing discussion, ask the patient to tell you about any other medicines they are taking, including recreational drugs and any remedies they buy without a prescription from the pharmacy, supermarket or health food store. AbbVie Limited. VIEKIRA PAK and VIEKIRA PAK-RBV Data Sheets. Medsafe New Zealand; Dec 2016. Where to find information on interactions 1. Medsafe-approved Data Sheet: www.medsafe.govt.nz • Please first refer to the New Zealand label for all contraindicated medications, drug interactions, and precautions. 2. University of Liverpool website: www.hep-druginteractions.org/ • Searchable by alphabetical list of drugs (A-Z), by drug class, or by trade name (see next slide) – search using OBV/PTV/r/DSV or VIEKIRA; – search for ribavirin separately • A mobile app is available. 3. Printed DDI Guide of interactions with common drugs in NZ: • Available from AbbVie or www.viekira.co.nz 4. AbbVie Medical Information: • 0800 900 030, or [email protected] AbbVie can answer questions based on data on file built up through the clinical development programme and post-marketing experience. NZ Data Sheet: drug interactions with VIEKIRA PAK NZ Data Sheet: drug interactions with VIEKIRA PAK *Contraindicated for treatment of pulmonary arterial hypertension; for erectile dysfunction, reduced dose frequency is recommended. †Contraindicated in Liverpool website but not NZ Data Sheet. ‡Weak interaction. This is not an exhaustive list; please refer This not an exhaustive list. Please to theisData Sheets and University of refer to the full Data Sheets and University of Liverpool’s Hep-Drug Interaction website. Liverpool’s Hep-Drug Interaction website. AbbVie Limited. VIEKIRA PAK and VIEKIRA PAK-RBV Data Sheets. Medsafe New Zealand; version 9: December 2016. AbbVie Limited.of VIEKIRA PAK and PAK-RBVPharmacology Data Sheets. Medsafe New Zealand; Drug Dec 2016. University Liverpool HIVVIEKIRA & HEPATITIS Group. Hepatitis Interactions. www.hep-druginteractions.org University of Liverpool website: http://hep-druginteractions.org/ Drug-drug interactions: University of Liverpool HEP Drug Interactions website Univerisity of Liverpool HIV & HEPATITIS Pharmacology Group. Hepatitis Drug Interactions. www.hepdruginteractions.org (Accessed Feb 2016). University of Liverpool HEP Drug Interactions app: the app is handy but the website is a more comprehensive resource Liverpool HIV & HEPATITIS Pharmacology Group. Hepatitis Drug Interactions. www.hep-druginteractions.org (Accessed Feb 2016). Example of drug with no interaction expected (green status) – methadone Search by Trade name (VIEKIRA PAK) or generic abbreviations (OBV/PTV/r + DSV) in A-Z tab Example of drug with potential interaction (amber status) – zopiclone Example of a potential interaction (amber status) – grapefruit juice Example of drug which must not be coadministered (red status) – carbamazepine Example of drug with a potential interaction with ribavirin – azathioprine For VIEKIRA PAK-RBV, search for OBV/PTV/r + DSV and ribavirin separately under the A-Z tab. Reporting of any adverse events An adverse event is any untoward medical occurrence in a patient given a medicinal product, including death, hospitalisation, surgery, or any worsening of a patient’s condition. It also includes overdose, abuse, or misuse; inadvertent, accidental, or occupational exposure; use during pregnancy or breastfeeding; lack of effect; medication error; suspected transmission of an infectious agent via a medicinal product; off-label use with an adverse event and unexpected benefit. To report an adverse event regarding VIEKIRA PAK or VIEKIRA PAK-RBV: Phone: AbbVie on 0800 900 030 Email: [email protected] • You will be sent an AbbVie Adverse Event form. Please send the completed form to [email protected] AbbVie Care Pharmacy Programme Next Steps What do I do next to become an AbbVie Care Pharmacist? • • Once you have confirmation of successful completion of your on-line training (with 8 digit code) go to www.viekira.co.nz (HCP login: username and password both GT1) Complete the on-line registration form by agreeing to the terms and conditions of the AbbVie Care Pharmacy Programme and entering your 8 digit code. If you experience any difficulties with the on-line registration, contact [email protected] for a copy of the form to complete. • • • • Your pharmacy details will be included on the pharmacy locator www.viekira.co.nz/locations and in the drop-down list on the PHARMAC on-line request form. You will receive a resource pack about the AbbVie Care Pharmacy Programme to commence patient dispensing. www.viekira.co.nz contains useful resources to support you as an AbbVie Care Pharmacy. PHARMAC and HCL will be made aware of your inclusion in the AbbVie Care Pharmacy Programme and patients will utilise your services to support them with the dispensing of VIEKIRA PAK/VIEKIRA PAK-RBV. VIEKIRA PAK and VIEKIRA PAK-RBV are fully funded Prescription Medicines on the Pharmaceutical Schedule with an alternative Xpharm distribution. Please review full Data Sheets before prescribing. These are available from AbbVie Limited at www.viekira.co.nz and from Medsafe at www.medsafe.govt.nz VIEKIRA PAK is a combination therapy containing paritaprevir/ritonavir/ombitasvir (75/50/12.5 mg) tablets and dasabuvir (250 mg) tablets. VIEKIRA PAK-RBV contains VIEKIRA PAK, plus ribavirin (200 mg*) tablets. INDICATIONS: VIEKIRA PAK and VIEKIRA PAK-RBV are indicated for the treatment of genotype 1 chronic hepatitis C, including patients with compensated cirrhosis, HIV-1 co-infection, and liver transplant patients. CONTRAINDICATIONS: VIEKIRA PAK: Severe hepatic impairment (Child-Pugh C); Hypersensitivity to components or excipients of VIEKIRA PAK or VIEKIRA PAK-RBV; Concomitant administration with: carbamazepine, colchicine (in renal or hepatic impairment), efavirenz, ergotamine and its derivatives, ethinyloestradiol-containing medicines (e.g. oral contraceptives), fusidic acid, gemfibrozil, oral midazolam, phenobarbital, phenytoin, rifampicin, St. John’s wort (Hypericum perforatum), salmeterol, sildenafil (when used for pulmonary arterial hypertension), simvastatin, terfenadine or triazolam. Please refer to the full Data Sheets for a complete list. VIEKIRA PAK-RBV As above, and: Pregnancy, including men whose partners are pregnant (Category X); Severe cardiac disease in previous 6 months; Haemoglobinopathies (e.g. thalassaemia, sickle-cell anaemia). PRECAUTIONS: VIEKIRA PAK: Not recommended for patients with moderate hepatic impairment (Child-Pugh B); Monitor changes in laboratory parameters including bilirubin and alanine transaminase (ALT); For patients with compensated cirrhosis, monitor for clinical signs and symptoms of hepatic decompensation or failure, and monitor liver function including bilirubin and alanine transaminase (ALT) according to local recommendations; Discontinue treatment in patients who develop evidence of hepatic decompensation or if ALT elevation is accompanied by signs or symptoms of liver inflammation or increasing conjugated bilirubin, alkaline phosphatase, or international normalised ratio (INR); Not recommended for patients with HCV genotypes other than 1; Not studied in patients previously treated with VIEKIRA PAK or other direct-acting antiviral agents; Not studied in patients younger than 18 or older than 70 years; Pregnancy (Category B3); Discontinue breastfeeding prior to initiation; Screen all patients for hepatitis B (HBV) before initiation of treatment. VIEKIRA PAK-RBV: As above, and: Use two forms of contraception to avoid pregnancy; Monitor haemoglobin in patients with pre-existing cardiac disease; Monitor uric acid in patients predisposed to gout; Reduce dose of ribavirin and monitor haemoglobin in patients with renal impairment. INTERACTIONS: See Data Sheets for medicines for which dose adjustment and/or monitoring should be considered. ADVERSE EFFECTS: VIEKIRA PAK: Fatigue, nausea, pruritus, insomnia and asthenia. VIEKIRA PAK-RBV: As above, and: anaemia, diarrhoea, vomiting, decreased appetite, dizziness, headache, sleep disorder, cough, dyspnoea, dry skin, and rash. DOSAGE AND ADMINISTRATION: VIEKIRA PAK: recommended dose is two paritaprevir/ritonavir/ombitasvir (75/50/12.5 mg) tablets once daily (in the morning) and one dasabuvir (250 mg) tablet taken with food twice daily (morning and evening) for 12 weeks. VIEKIRA PAK-RBV: As above, for 12 or 24 weeks, with ribavirin. The recommended dose of ribavirin depends on a patient's bodyweight (<75 kg = 1000 mg; ≥75 kg = 1200 mg), and should be taken with food in two divided doses (morning and evening). Ribavirin monotherapy is not effective and ribavirin must only be used in combination with VIEKIRA PAK. See full Data Sheets for additional information on duration of therapy and use in special populations. *Other presentations including ribavirin 400 mg and/or 600 mg tablets are not currently available in New Zealand. The HCP username and password for www.viekira.co.nz are both GT1. AbbVie is a registered Trademark of AbbVie Inc. VIEKIRA PAK is a registered Trademark of AbbVie Ireland Unlimited Company. ©2017. AbbVie Limited, PO Box 11437, Manners Street, Wellington 6142, New Zealand.) NZ-HCV-0038 TAPS PP8629 Prepared March 2017.