Oxfordshire Clinical Commissioning Group HYDROXYCHLOROQUINE FOR USE IN ADULT AND PAEDIATRIC RHEUMATOLOGY Shared Care Protocol This protocol provides prescribing and monitoring guidance for hydroxychloroquine therapy. It should be read in conjunction with the shared care responsibilities, the Summary of Product Characteristics (SPC) available on www.medicines.org.uk/emc and the BNF. BACKGROUND FOR USE Hydroxychloroquine (HCQ) is a disease modifying anti-rheumatic drug (DMARD). It is used to treat: Systemic lupus erythematosus (SLE) (licensed) Rheumatoid arthritis (licensed) Juvenile Systemic Lupus Erythematosus Juvenile Dermatomyositis and Sarcoidosis Juvenile Idiopathic Arthritis Its use in this protocol includes the above two indications. In rheumatology it is often used in combination with other DMARDs, such as methotrexate or sulfasalazine. For all renal patients, supply of this medication will be provided in secondary care. CONTRAINDICATIONS AND PRECAUTIONS CONTRAINDICATION Pre-existing maculopathy Avoid Breastfeeding Avoid PRECAUTIONS Epilepsy May reduce threshold for convulsions Severe gastro-intestinal disorders Use with caution Psoriasis May exacerbate skin symptoms Moderate to severe hepatic and renal impairment and drugs which cause renal and hepatic toxicity Use with caution Pregnancy HCQ has been used relatively safely in pregnancy. The risk of stopping therapy must be weighed against the small possible risk to the unborn child. Myasthenia gravis May aggravate symptoms HCQ treatment for more than five years Discuss with ophthalmologist Approved by APCO May 2015 1 of 4 Uncontrolled if printed Vaccinations Live vaccines such as oral polio, rubella, MMR, BCG and yellow fever should not be given due to the risk of increased antigenic reaction and possible reduced immunological response. Pneumovax is recommended Annual flu vaccines are safe and recommended. Remember, for paediatric patients Fluenz Tetra® (nasal flu vaccine) is live so should not be used. DOSAGE1 Rheumatology indications: Typical regimen 200 – 400 mg orally daily Maximum dose 6.5 mg/kg daily (but not exceeding 400 mg daily) Doses should be calculated using ideal body weight for obese patients Time to response is 3 to 6 months Paediatric Indications: Prescribed according to weight: 5- 6.5mg/kg/day in one or two divided doses. Prescribe according to ideal body weight especially in overweight children to reduce risk of ocular toxicity Maximum 400mg per day. Benefit is seen after 6 to 8 weeks, improvement may continue over a further 4 to 6 months. Hydroxychloroquine is available as 200mg tablets. Tablets may be halved or crushed and dispersed in water. In children unable to take solid dosage forms, a specially manufactured liquid is required. Review regularly and switch to tablets as soon as the child can take them. PRE-TREATMENT ASSESSMENT BY SPECIALIST FBC, LFTs, U&Es, CRP. Antimalarials can cause retinal damage, but recent studies show that this occurs less frequently with hydroxychloroquine than chloroquine. The Royal College of Ophthalmologists has produced guidance for screening to prevent ocular toxicity on long-term treatment with chloroquine and hydroxychloroquine1: Patients should be asked about visual impairment (not corrected by glasses). If abnormality detected, refer to ophthalmologist. Check near visual acuity of each eye (with glasses if appropriate) using a standard reading chart. Counsel patient to attend optometrist annually for visual acuity test. Bring test results to the next appointment. ONGOING MONITORING SCHEDULE Parameter Frequency Blood tests Not required for detecting toxicity. Disease monitoring Ongoing monitoring to be done by specialist in accordance with clinical need. Approved by APCO May 2015 2 of 4 Uncontrolled if printed Ask about visual symptoms including blurred vision. Request all patients to attend optometrist for visual acuity test and provide test report. Annually ACTIONS TO BE TAKEN Side Effect Action Change in visual acuity or development of blurred vision Gastrointestinal disturbance Skin rashes Withhold treatment. Discuss with specialist who may arrange a review by ophthalmologist. If severe, drug may have to be discontinued. Often photosensitive. Stop in all but the mildest of cases. HCQ is very toxic in over dosage. Immediate advice from the Poisons Centre is essential. Children presenting within 1 hour of ingesting doses greater than 20mg/kg should be considered for activated charcoal 1mg/kg. Over dosage Notes: Hydroxychloroquine can be withheld for 2-3 weeks without inducing a flare. Hydroxychloroquine should not be stopped prior to elective surgery. NOTABLE DRUG INTERACTIONS Antacids: Reduce absorption of hydroxychloroquine and should be avoided within 4 hours of dose. Moxifloxacin, amiodarone, quinine: Increase risk of cardiac arrhythmias if used with hydroxychloroquine and should be avoided. Mefloquine: Increased risk of convulsions if used with hydroxychloroquine and should be avoided. Digoxin, ciclosporin, methotrexate: Hydroxychloroquine may increase plasma concentration of these drugs. Note that in practice, hydroxychloroquine and methotrexate are often used together, with dose adjustments. Neostigmine and pyridostigmine effects are diminished by hydroxychloroquine, causing increased symptoms of myasthenia gravis. Avoid concomitant use. NSAIDs may be continued. BACK-UP INFORMATION AND ADVICE Contact Details Oxford University Hospitals NHS Trust Rheumatology Rheumatology Helpline (Adult and Paediatric) Rheumatology Senior Registrar on call Medicines Information 01865 737656 01865 741155, ask for SR on call via switchboard. Tel 01865 221505 REFERENCES 1. Royal College of Ophthalmologists. Hydroxychloroquine and ocular toxicity: Recommendation on screening, 2009 Approved by APCO May 2015 3 of 4 Uncontrolled if printed 2. BNF 68, September 2014-March 2015 3. Hydroxychloroquine SPC, http://www.medicines.org.uk/emc/ last updated 25/03/14 4. BSPAR (British Society for Paediatric and Adolescent Rheumatology) Clinical Guidelines 2010 – Hydroxychloroquine Acknowledge: Adapted from Buckinghamshire CCG Shared Care Protocols. Approved by APCO May 2015 4 of 4 Uncontrolled if printed