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▶ Rare or very rare Allergic rhinitis . arthralgia . asthenia . asthma . constipation . dizziness . dry mouth . dysphonia . dyspnoea . gastrointestinal disorders . hypertension . hypotension . madarosis . musculoskeletal pain . ophthalmic herpes simplex . oropharyngeal pain . respiratory disorder.taste altered

▶ Frequency not known Abdominal pain . anxiety . arrhythmias . chest pain . depression . diarrhoea . epistaxis . insomnia . nausea .tinnitus . urinary disorders . vertigo . vomiting

l PREGNANCY Manufacturer advises avoid unless potential

benefit outweighs risk—toxicity in animal studies.

l BREAST FEEDING Present in milk in animal studies;

manufacturer advises avoid.

l PATIENT AND CARER ADVICE

Changes to eye colour Before initiating treatment, patients

should be warned of a possible change in eye colour as an

increase in the brown pigment in the iris can occur, which

may be permanent; particular care is required in those

with mixed coloured irides and those receiving treatment

to one eye only. Changes in eyelashes and vellus hair can

also occur, and patients should also be advised to avoid

repeated contact of the eye drop solution with skin as this

can lead to hair growth or skin pigmentation.

l MEDICINAL FORMS There can be variation in the licensing of

different medicines containing the same drug.

Eye drops

EXCIPIENTS: May contain Propylene glycol

▶ Travoprost (Non-proprietary)

Travoprost 40 microgram per 1 ml Travoprost 40micrograms/ml

eye drops | 2.5 ml P £3.24–£10.95 DT = £3.24

▶ Bondulc (Actavis UK Ltd)

Travoprost 40 microgram per 1 ml Bondulc 40micrograms/ml eye

drops | 2.5 ml P £10.94 DT = £3.24

▶ Travatan (Novartis Pharmaceuticals UK Ltd)

Travoprost 40 microgram per 1 ml Travatan 40micrograms/ml eye

drops | 2.5 ml P £10.95 DT = £3.24

1186 Glaucoma and ocular hypertension BNF 78

Eye

11

Travoprost with timolol

The properties listed below are those particular to the

combination only. For the properties of the components

please consider, travoprost p. 1186, timolol maleate p. 1180.

l INDICATIONS AND DOSE

Raised intra-ocular pressure in patients with open-angle

glaucoma or ocular hypertension when beta-blocker or

prostaglandin analogue alone not adequate

▶ TO THE EYE

▶ Adult: Apply once daily

l INTERACTIONS → Appendix 1: beta blockers, non-selective

l MEDICINAL FORMS There can be variation in the licensing of

different medicines containing the same drug.

Eye drops

EXCIPIENTS: May contain Propylene glycol

▶ Travoprost with timolol (Non-proprietary)

Travoprost 40 microgram per 1 ml, Timolol (as Timolol maleate)

5 mg per 1 ml Travoprost 40micrograms/ml / Timolol 5mg/ml eye

drops | 2.5 ml P £13.95 DT = £13.95

▶ DuoTrav (Novartis Pharmaceuticals UK Ltd)

Travoprost 40 microgram per 1 ml, Timolol (as Timolol maleate)

5 mg per 1 ml DuoTrav 40micrograms/ml / 5mg/ml eye drops |

2.5 ml P £13.95 DT = £13.95 | 7.5 ml P £39.68

SYMPATHOMIMETICS › ALPHA2-ADRENOCEPTOR

AGONISTS

Apraclonidine 28-May-2018

l DRUG ACTION Apraclonidine is an alpha2-adrenoceptor

agonist that lowers intra-ocular pressure by reducing

aqueous humour formation. It is a derivative of clonidine.

l INDICATIONS AND DOSE

Control or prevention of postoperative elevation of intraocular pressure after anterior segment laser surgery

▶ TO THE EYE

▶ Adult: Apply 1 drop, 1 hour before laser procedure,

then 1 drop, immediately after completion of

procedure, 1% eye drops to be administered

Short-term adjunctive treatment of chronic glaucoma in

patients not adequately controlled by another drug

▶ TO THE EYE

▶ Adult: Apply 1 drop 3 times a day usually for maximum

1 month, 0.5% eye drops to be administered, may not

provide additional benefit if patient already using two

drugs that suppress the production of aqueous humour

l CONTRA-INDICATIONS History of severe or unstable and

uncontrolled cardiovascular disease

l CAUTIONS Cerebrovascular disease . depression . heart

failure . history of angina . hypertension. loss of effect may

occur over time . Parkinson’s syndrome . Raynaud’s

syndrome .recent myocardial infarction .reduction in

vision in end-stage glaucoma (suspend treatment). severe

coronary insufficiency .thromboangiitis obliterans . vasovagal attack

l INTERACTIONS → Appendix 1: apraclonidine

l SIDE-EFFECTS

▶ Common or very common Eye disorders

▶ Uncommon Bradycardia . conjunctival haemorrhage . diarrhoea . dry eye . eye discomfort. eye inflammation . gastrointestinal discomfort. irritability . libido decreased . nasal dryness . palpitations . postural hypotension . sensation abnormal . sleep disorders . syncope . vision

disorders . vomiting

▶ Rare or very rare Chest pain . dry mouth . fatigue . headache . hyperhidrosis . pain in extremity . pruritus . taste altered .temperature sensation altered

SIDE-EFFECTS, FURTHER INFORMATION Since absorption

may follow topical application, systemic effects may

occur– see clonidine hydrochloride p. 145.

Ocular intolerance Manufacturer advises withdrawal if

eye pruritus, ocular hyperaemia, increased lacrimation, or

oedema of the eyelids and conjunctiva occur.

l PREGNANCY Manufacturer advises avoid—no information

available.

l BREAST FEEDING Manufacturer advises avoid—no

information available.

l HEPATIC IMPAIRMENT Manufacturer advises use with

caution and monitor, including close monitoring of

cardiovascular parameters—no information available.

l RENAL IMPAIRMENT Use with caution in chronic renal

failure.

l MONITORING REQUIREMENTS

▶ Monitor intra-ocular pressure and visual fields.

▶ Monitor for excessive reduction in intra-ocular pressure

following peri-operative use.

l PATIENT AND CARER ADVICE

Driving and skilled tasks Drowsiness may affect

performance of skilled tasks (e.g. driving).

l MEDICINAL FORMS There can be variation in the licensing of

different medicines containing the same drug.

Eye drops

EXCIPIENTS: May contain Benzalkonium chloride

▶ Iopidine (Novartis Pharmaceuticals UK Ltd)

Apraclonidine (as Apraclonidine hydrochloride) 5 mg per

1 ml Iopidine 5mg/ml eye drops | 5 ml P £10.88 DT = £10.88

Apraclonidine (as Apraclonidine hydrochloride) 10 mg per

1 ml Iopidine 1% eye drops 0.25ml unit dose | 24 unit dose P £77.85 DT = £77.85

Brimonidine tartrate 12-Jul-2017

l DRUG ACTION Brimonidine, an alpha2-adrenoceptor

agonist, is thought to lower intra-ocular pressure by

reducing aqueous humour formation and increasing

uveoscleral outflow.

l INDICATIONS AND DOSE

Raised intra-ocular pressure in open-angle glaucoma in

patients for whom beta-blockers are inappropriate |

Ocular hypertension in patients for whom beta-blockers

are inappropriate | Adjunctive therapy when intra-ocular

pressure is inadequately controlled by other

antiglaucoma therapy

▶ TO THE EYE

▶ Adult: Apply twice daily

l CAUTIONS Cerebral insufficiency . coronary insufficiency . depression . postural hypotension . Raynaud’s syndrome . severe cardiovascular disease .thromboangitis obliterans

l INTERACTIONS → Appendix 1: brimonidine

l SIDE-EFFECTS

▶ Common or very common Asthenia . dizziness . drowsiness . dry eye . dry mouth . eye discomfort. eye disorders . eye

inflammation . gastrointestinal disorder. headache . hyperaemia . hypersensitivity . pulmonary reaction . sensation of foreign body . skin reactions .taste altered . vision disorders

▶ Uncommon Arrhythmias . nasal dryness . palpitations

▶ Rare or very rare Dyspnoea . hypertension. hypotension . insomnia . syncope

▶ Frequency not known Face oedema . vasodilation

l PREGNANCY Manufacturer advises use only if benefit

outweighs risk—limited information available.

l BREAST FEEDING Manufacturer advises avoid—no

information available.

BNF 78 Glaucoma and ocular hypertension 1187

Eye

11

l HEPATIC IMPAIRMENT Manufacturer advises caution (no

information available).

l RENAL IMPAIRMENT Manufacturer advises use with

caution.

l PATIENT AND CARER ADVICE

Driving and skilled tasks Drowsiness may affect

performance of skilled tasks (e.g. driving).

l MEDICINAL FORMS There can be variation in the licensing of

different medicines containing the same drug.

Eye drops

EXCIPIENTS: May contain Benzalkonium chloride

▶ Brimonidine tartrate (Non-proprietary)

Brimonidine tartrate 2 mg per 1 ml Brimonidine 2mg/ml eye drops

| 5 ml P s DT = £3.04

Brimonidine 0.2% eye drops | 5 ml P £3.98 DT = £3.04

▶ Alphagan (Allergan Ltd)

Brimonidine tartrate 2 mg per 1 ml Alphagan 0.2% eye drops | 5 ml P £6.85 DT = £3.04

▶ Brymont (Blumont Pharma Ltd)

Brimonidine tartrate 2 mg per 1 ml Brymont 2mg/ml eye drops | 5 ml P £1.50 DT = £3.04

Combinations available: Brinzolamide with brimonidine,

p. 1182

Brimonidine with timolol

The properties listed below are those particular to the

combination only. For the properties of the components

please consider, brimonidine tartrate p. 1187, timolol

maleate p. 1180.

l INDICATIONS AND DOSE

Raised intra-ocular pressure in open-angle glaucoma and

for ocular hypertension when beta-blocker alone not

adequate

▶ TO THE EYE

▶ Adult: Apply twice daily

l INTERACTIONS → Appendix 1: beta blockers, non-selective . brimonidine

l MEDICINAL FORMS There can be variation in the licensing of

different medicines containing the same drug.

Eye drops

EXCIPIENTS: May contain Benzalkonium chloride

▶ Combigan (Allergan Ltd)

Brimonidine tartrate 2 mg per 1 ml, Timolol (as Timolol maleate)

5 mg per 1 ml Combigan eye drops | 5 ml P £10.00 DT = £10.00

| 15 ml P £27.00

6 Retinal disorders

6.1 Macular degeneration

Age-related macular degeneration

25-Apr-2018

Description of condition

Age-related macular degeneration is a progressive eye

condition that affects the central area of the retina (macula).

It occurs mainly in people aged 55 years and over and is a

common cause of vision loss. The progressive loss of central

vision affects the patient’s ability to see well enough to

recognise faces, drive, and to read and write. Although the

exact cause is unknown, known risk factors in addition to

increasing age include smoking and a family history of agerelated macular degeneration.

There are two types of age-related macular degeneration—

dry and wet. Dry (non-neovascular) age-related macular

degeneration progresses slowly as extensive wasting of

macula cells occurs. Whereas, with wet (neovascular) agerelated macular degeneration, new blood vessels develop

beneath and within the retina, and can lead to a rapid

deterioration of vision. Wet age-related macular

degeneration is further classified as wet-active (neovascular

lesions that may benefit from treatment) and wet-inactive

(neovascular disease with irreversible structural change).

Aims of treatment

The aim of treatment is to slow down the progression of agerelated macular degeneration and central vision loss;

treatment is initiated under specialist care.

Treatment

Treatment is dependent on the stage and type of age-related

macular degeneration, with drug treatment only

recommended in patients with wet-active age-related

macular degeneration. Counselling and support, advice on

Smoking cessation p. 497, and use of visual aids is

recommended in all patients with age related macular

degeneration as appropriate.

g An intravitreal anti-vascular endothelial growth

factor (anti-VEGF), such as aflibercept p. 1008, ranibizumab

p. 1190, or bevacizumab p. 862 [unlicensed use], is first-line

treatment for patients with wet-active age-related macular

degeneration who have a visual acuity between 6/12 and

6/96. If visual acuity is less than 6/96, anti-VEGF treatment

should only be given if the patient’s overall visual function is

likely to improve (e.g. if the affected eye is the patient’s

better-seeing eye). Anti-VEGF treatment should only be

administered by healthcare professionals experienced in the

use of intravitreal injections. See also National

funding/access decisions for aflibercept p. 1008 and

ranibizumab p. 1190.

Treatment should be stopped if the patient develops

severe, progressive loss of visual acuity despite treatment, or

if the patient’s age-related macular degeneration develops

into wet-inactive with no prospect of visual function

improvement. A treatment-free period can be considered in

patients whose age-related macular degeneration appears to

be stable.

Photodynamic therapy alone should not be given to

patients with wet-active age-related macular degeneration. It

can be given as an adjunct to anti-VEGF treatment as a

second-line option in the context of a randomised controlled

trial. Intravitreal corticosteroids are not recommended in

combination with anti-VEGF treatment because there is

limited evidence of benefit to a patient’s visual acuity.

Patients should be advised to attend routine sight tests,

self-monitor, and to report any changes in vision such as

appearance of grey patches or blurred vision, straight lines

appearing distorted, and objects appearing smaller than

normal. h

Useful Resources

Age-related macular degeneration. National Institute for

Health and Care Excellence. NICE guideline 82. January

2018.

www.nice.org.uk/guidance/ng82

1188 Retinal disorders BNF 78

Eye

11

ANTINEOVASCULARISATION DRUGS ›

VASCULAR ENDOTHELIAL GROWTH FACTOR

INHIBITORS

Aflibercept 06-Dec-2017

l DRUG ACTION Aflibercept is a recombinant fusion protein

that acts as a soluble decoy receptor and binds to vascular

endothelial growth factors A and B (VEGF-A, VEGF-B) and

placental growth factor (PlGF). Aflibercept inhibits the

activation of VEGF receptors and the proliferation of

endothelial cells, thereby inhibiting the growth of new

vessels.

l INDICATIONS AND DOSE

Neovascular (wet) age-related macular degeneration

(specialist use only)

▶ BY INTRAVITREAL INJECTION

▶ Adult: Initially 2 mg once a month for 3 months, then

2 mg every 2 months, review treatment frequency after

12 months

Macular oedema secondary to retinal vein occlusion

(specialist use only)

▶ BY INTRAVITREAL INJECTION

▶ Adult: Initially 2 mg once a month until maximum

visual acuity is achieved or there are no signs of disease

activity (discontinue treatment if no improvement in

visual and anatomic outcomes)

Diabetic macular oedema (specialist use only)

▶ BY INTRAVITREAL INJECTION

▶ Adult: Initially 2 mg once a month for 5 months, then

maintenance 2 mg every 2 months, review treatment

frequency after 12 months (discontinue treatment if no

improvement in visual and anatomic outcomes)

Myopic choroidal neovascularisation (specialist use only)

▶ BY INTRAVITREAL INJECTION

▶ Adult: 2 mg for 1 dose, if visual or anatomic outcomes

indicate that disease persists, additional doses may be

administered; the interval between 2 doses should be

greater than 1 month

l CONTRA-INDICATIONS Clinical signs of irreversible

ischaemic visual function loss . ocular or periocular

infection . severe intra-ocular inflammation

l CAUTIONS Active systemic infection . diabetic patients

with uncontrolled hypertension . discontinue treatment if

stage 3 or 4 macular holes develop—consult product

literature for full details . discontinue treatment in the

event of a retinal break—consult product literature for full

details . discontinue treatment in the event of

rhegmatogenous retinal detachment—consult product

literature for full details . patients at risk of retinal pigment

epithelial tear. poorly controlled glaucoma .recent history

of myocardial infarction .recent history of stroke .recent

history of transient ischaemic attack

CAUTIONS, FURTHER INFORMATION Aflibercept is given by

intravitreal injection by specialists experienced in the

management of this condition. There is a potential risk of

arterial thromboembolic events and non-ocular

haemorrhage following the intravitreal injection of

vascular endothelial growth factor inhibitors.

Endophthalmitis can occur after intravitreal injections—

patients should be advised to report any signs of infection

immediately.

l INTERACTIONS → Appendix 1: aflibercept

l SIDE-EFFECTS

▶ Common or very common Cataract. eye discomfort. eye

disorders . eye inflammation . haemorrhage .retinal

pigment epithelial tear. vision disorders

▶ Uncommon Lens opacity

l CONCEPTION AND CONTRACEPTION Manufacturer

recommends women use effective contraception during

and for at least 3 months after treatment.

l PREGNANCY Manufacturer advises avoid unless potential

benefit outweighs risk.

l BREAST FEEDING Manufacturer advises avoid—no

information available.

l HEPATIC IMPAIRMENT Manufacturer advises caution in

severe impairment (no information available).

l MONITORING REQUIREMENTS Monitor intra-ocular

pressure following injection.

l DIRECTIONS FOR ADMINISTRATION For further information

on administration, consult product literature.

l NATIONAL FUNDING/ACCESS DECISIONS

NICE decisions

▶ Aflibercept solution for injection for treating wet age-related

macular degeneration (July 2013) NICE TA294

Aflibercept solution for injection is recommended as an

option for treating wet age-related macular degeneration

only if:

. it is used in accordance with the recommendations for

ranibizumab in NICE TA 155 and

. the manufacturer provides aflibercept solution for

injection with the discount agreed in the patient access

scheme

www.nice.org.uk/guidance/TA294

▶ Aflibercept for treating visual impairment caused by macular

oedema secondary to central retinal vein occlusion (February

2014) NICE TA305

Aflibercept solution for injection is recommended as an

option for treating visual impairment caused by macular

oedema secondary to central retinal vein occlusion only if

the manufacturer provides aflibercept solution for

injection with the discount agreed in the patient access

scheme.

www.nice.org.uk/guidance/TA305

▶ Aflibercept for treating diabetic macular oedema (July 2015)

NICE TA346

Aflibercept solution for injection is recommended as an

option for treating visual impairment caused by diabetic

macular oedema only if:

. the eye has a central retinal thickness of

400 micrometres or more at the start of treatment and

. the manufacturer provides aflibercept with the discount

agreed in the patient access scheme.

www.nice.org.uk/guidance/TA346

▶ Aflibercept for treating visual impairment caused by macular

oedema after branch retinal vein occlusion (September 2016)

NICE TA409

Aflibercept is recommended, within its marketing

authorisation, as an option for treating visual impairment

in adults caused by macular oedema after branch retinal

vein occlusion, only if the manufacturer provides

aflibercept with the discount agreed in the patient access

scheme.

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