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XALACOM (latanoprost and timolol ophthalmic solution (as timolol maleate) Adverse Reactions

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Adverse Reactions

Clinical Trial Adverse Drug Reactions

Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates.

XALACOM (latanoprost and timolol maleate) was generally well tolerated. No adverse events specific to XALACOM have been observed in clinical studies. The adverse events have been limited to those that were reported previously with latanoprost and/or timolol maleate.

XALACOM was evaluated for safety in 394 patients with open-angle glaucoma or ocular hypertension in three long-term studies. Two percent (2%) of patients discontinued therapy with XALACOM due to adverse events.

Adverse events occurring at a frequency of > 1% in three randomized, double blind comparative trials (004, 005 and 053) are presented in Tables 1 and 2.

Table 1
Ocular adverse events (AE) that occurred in ≥ 1% of patients*, in any treatment group, by preferred term†
*
Despite a low frequency of reports, some AEs are included in the listing due to the implication of a potentially sight-threatening condition.
**
A patient is counted only once per preferred term
Studies 004 and 005 included a 6 month and 053 a 12 month double-blinded period
Include*s darkening, lengthening and growing of eye lashes
 

Number (%) of patients per treatment group

Body system / preferred term

XALACOM

N=394

Latanoprost

N=414

Timolol

N=415

Vision

Blepharitis

10 (2.5)

10 (2.4)

7 (1.7)

Cataract

11 (2.8)

18 (4.3)

10 (2.4)

Conjunctival disorder

4 (1.0)

3 (0.7)

4 (1.0)

Conjunctivitis

12 (3.0)

11 (2.7)

13 (3.1)

Corneal disorder

12 (3.0)

11 (2.7)

14 (3.4)

Corneal ulceration

1 (0.3)*

1 (0.2)*

-

Cystoid macular oedema

1 (0.3)**

1 (0.2)*

-

Epiphora

3 (0.8)

5 (1.2)

7 (1.7)

Errors of refraction

7 (1.8)

13 (3.1)

12 (2.9)

Eye hyperaemia

29 (7.4)

40 (9.7)

12 (2.9)

Eye pain

9 (2.3)

6 (1.4)

8 (1.9)

Increased intraocular pressure

1 (0.3)

5 (1.2)

7 (1.7)

Iris hyperpigmentation

6 (1.5)

13 (3.1)

4 (1.0)

Iritis

-

1 (0.2)*

2 (0.5)*

Irritation eye (burning, grittiness, itching, stinging and foreign body sensation)

49 (12.4)

54 (13.0)

29 (7.0)

Keratitis

4 (1.0)

3 (0.7)

1 (0.2)

Oedema eyelid

2 (0.5)

4 (1.0)

2 (0.5)

Photophobia

6 (1.5)

1 (0.2)

3 (0.7)

Retinal disorder

1 (0.3)

3 (0.7)

6 (1.4)

Uveitis

1 (0.3)*

-

-

Vision abnormal

26 (6.6)

29 (7.0)

22 (5.3)

Skin & Appendages

Hypertrichosis‡

9 (2.3)

6 (1.4)

2 (0.5)

Pigmentation abnormal

1 (0.3)*

-

-

Seborrhoea

2 (0.5)

4 (1.0)

-

Skin discolouration

1 (0.3)*

-

-

Skin disorder

8 (2.0)

4 (1.0)

-

Central & Peripheral Nervous System

Optic atrophy

2 (0.5)

3 (0.7)

6 (1.4)

Visual field defect

18 (4.6)

19 (4.6)

18 (4.3)

Table 2:
Systemic adverse events (AE) that occurred in ≥1% of patients*, in any of the treatment groups, by body system/preferred term†
*
A patient is counted only once per preferred term. AEs that occurred in <1 % of the patients but were very similar to an event that did occur in > 1% of the patients (such as “hypertension” and “hypertension aggravated”) are listed. Also, groups of mutually related AEs, where each AE may be reported in < 1%, but together they sum up to ≥ 1% (such as “diabetes mellitus aggravated” and “hyperglycaemia” together with “glucosuria”) are summarised.
Studies 004 and 005 included a 6 month- and 053 a 12 month double-blinded period
 

Number (%) of patients per treatment group

Body system / preferred term

XALACOM

N=394

Latanoprost

N=414

Timolol

N=415

Respiratory

Bronchitis

3 (0.8)

4 (1.0)

1 (0.2)

Coughing

1 (0.3)*

-

2 (0.5)*

Dyspnoea

2 (0.5)*

2 (0.5)*

2 (0.5)*

Pneumonia

1 (0.3)

3 (0.7)

4 (1.0)

Sinusitis

6 (1.5)

11 (2.7)

3 (0.7)

Upper respiratory tract infection

24 (6.1)

18 (4.3)

22 (5.3)

General

Back pain

4 (1.0)

6 (1.4)

4 (1.0)

Chest pain

4 (1.0)

1 (0.2)

2 (0.5)

Influenza-like symptoms

10 (2.5)

4 (1.0)

3 (0.7)

Cardiovascular

Hypertension

15 (3.8)

6 (1.4)

10 (2.4)

Hypertension aggravated

2 (0.5)*

1 (0.2)*

1 (0.2)*

Metabolic & Nutrition

Diabetes mellitus

5 (1.3)

2 (0.5)

1 (0.2)

Diabetes mellitus aggravated

-

1 (0.2)

-

Glycosuria

2 (0.5)

1 (0.2)

-

Hyperglycaemia

1 (0.3)*

2 (0.5)*

2 (0.5)*

Hypercholesterolaemia

6 (1.5)

4 (1.0)

1 (0.2)

Central & Peripheral Nervous System

Dizziness

2 (0.5)

4 (1.0)

1 (0.2)

Headache

9 (2.3)

15 (3.6)

5 (1.2)

Musculo-Skeletal

Arthritis

8 (2.0)

5 (1.2)

4 (1.0)

Psychiatric

Depression

6 (1.5)

7 (1.7)

4 (1.0)

Insomnia

1 (0.3)*

1 (0.2)*

1 (0.2)*

Sleep disorder

1 (0.3)

-

4 (1.0)

Skin & Appendages

Bullous eruption

-

1 (0.2)

-

Rash

5 (1.3)

3 (0.7)

2 (0.5)

Resistance Mechanisms

Infection

4 (1.0)

6 (1.4)

(1.4)

Gastro-Intestinal

Dyspepsia

2 (0.5)

4 (1.0)

1 (0.2)

Urinary

Cystitis

1 (0.3)

5 (1.2)

-

Urinary tract infection

1 (0.3)

2 (0.5)

4 (1.0)

Based on evidence from consecutive photographs, increased iris pigmentation was observed in 16-20% of patients treated with XALACOM for up to one year. The most frequent findings of increased iris pigmentation were in the known high-risk eye color groups, i.e. those with green-brown, yellow-brown, and blue/gray-brown irises. In patients with homogeneously blue, grey, green or brown eyes, the change was rarely observed. Darkening, thickening and lengthening of eye lashes were observed in 37.4% of patients.

Post-Market Adverse Drug Reactions

The following additional adverse events that have been reported with latanoprost and timolol eye drops:

Latanoprost

System Organ Class

Adverse Drug Reactions

Cardiac disorders

Angina unstable, angina, palpitations

Eye disorders

Foreign body sensation, macular oedema including cystoid macular oedema, corneal erosion, punctate keratitis, corneal oedema, uveitis, iritis, pseudopemphigoid of ocular conjunctiva, trichiasis, photophobia, vision blurred, eyelash and vellus hair changes of the eyelid (increased length, thickness, pigmentation, and number of eyelashes), localised skin reaction on the eyelids, iris cyst, periorbital and lid changes resulting in deepening of the eyelid sulcus, darkening of the palpebral skin of the eyelids

General disorders and administration site conditions

Chest pain

Infections and infestations

Herpetic keratitis

Musculoskeletal and connective tissue disorders

Myalgia, arthralgia

Nervous system disorders

Dizziness

Respiratory, thoracic and mediastinal disorders

Acute asthma attacks, asthma aggravation, asthma, dyspnoea

Skin and subcutaneous tissue disorders

Pruritus

Timolol Maleate (topical formulation)

System Organ Class

Adverse Drug Reactions

Cardiac disorders

Cardiac arrest, cardiac failure, heart block, atrioventricular block, congestive heart failure, worsening of angina pectoris, arrhythmia, bradycardia, palpitation

Ear and labyrinth disorders

Tinnitus

Eye disorders

Cystoid macular oedema, choroidal detachment (following filtration surgery), corneal erosion, keratitis, diplopia, decreased corneal sensitivity, signs and symptoms of ocular irritation (e.g., burning, stinging, itching, tearing, redness), dry eyes, ptosis, blepharitis, visual disturbances including refractive changes (due to withdrawal of miotic therapy in some cases), vision blurred

Gastrointestinal disorders

Retroperitoneal fibrosis, abdominal pain, vomiting, diarrhoea, dry mouth, dysgeusia, dyspepsia, nausea

General disorders and administration site conditions

Chest pain, oedema, asthenia, fatigue

Immune system disorders

Signs and symptoms of systemic allergic reactions including anaphylaxis, angioedema, urticaria, pruritus, localized and generalized rash

Metabolism and nutrition disorders

Masked symptoms of hypoglycaemia in diabetic patients, anorexia

Musculoskeletal and connective tissue disorders

Myalgia, systemic lupus erythematosus

Nervous system disorders

Cerebral vascular accident, cerebral ischemia, dizziness, increase in signs and symptoms of myasthenia gravis, paraesthesia, somnolence, headache, syncope

Psychiatric disorders

Behavioural changes and psychic disturbances including, confusion, hallucinations, anxiety, disorientation, nervousness, depression, insomnia, nightmares, memory loss

Reproductive system and breast disorders

Sexual dysfunction, decreased libido, impotence, Peyronie’s disease

Respiratory, thoracic and mediastinal disorders

Respiratory failure, pulmonary oedema, bronchospasm (predominantly in patients with pre-existing bronchospastic disease), cough, dyspnoea, nasal congestion

Skin and subcutaneous tissue disorders

Skin rash, psoriasiform rash, pseudopemphigoid, exacerbation of psoriasis, alopecia

Vascular disorders

Claudication, cold hands and feet, hypotension, Raynaud’s phenomenon

Cases of corneal calcification have been reported very rarely in association with the use of phosphate-containing eye drops in some patients with significantly damaged corneas.

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