DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Lucentis (Ranibizumab) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Injection Procedure

Serious adverse reactions related to the injection procedure occurring in <0.1% of intravitreal injections included endophthalmitis [see Warnings and Precautions], rhegmatogenous retinal detachments, and iatrogenic traumatic cataracts.

Clinical Studies Experience‑ Ocular Reactions

Other serious ocular adverse reactions observed among LUCENTIS‑treated patients occurring in <2% of patients included intraocular inflammation and increased intraocular pressure [see Warning and Precautions (5.1, 5.2) ].

The available safety data include exposure to LUCENTIS in 874 patients with neovascular age-related macular degeneration in three double-masked, controlled studies with dosage regimens of 0.3 mg (375 patients) or 0.5 mg (379 patients) administrered monthly by intravitreal injection (Studies 1 and 2) [see Clinical Studies], and dosage regimens of 0.3 mg (59 patients) or 0.5 mg (61 patients) administered once a month for 3 consecutive doses followed by a dose administered once every 3 months (Study 3) [see Clinical Studies].

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of one drug cannot be directly compared with rates in the clinical trials of the same or another drug and may not reflect the rates observed in practice.

Table 1 shows the most frequently reported ocular adverse reactions that were reported with LUCENTIS treatment, for which the point estimates were higher in the LUCENTIS group compared with the control group. The ranges represent the maximum and minimum rates across all three studies for control, and across all three studies and both dose groups for LUCENTIS.

Table 1
Adverse ReactionLUCENTISControl
Conjunctival hemorrhage77%–43%66%–29%
Eye pain37%–17%33%–11%
Vitreous floaters32%–3%10%–3%
Intraocular pressure increased24%–8%7%–3%
Intraocular inflammation18%–5%11%–3%
Eye irritation19%–4%20%–6%
Cataract16%–5%16%–6%
Foreign body sensation in eyes19%–6%14%–6%
Lacrimation increased17%–3%16%–0%
Eye pruritis13%–0%12%–3%
Visual disturbance14%–0%9%–2%
Blepharitis13%–3%9%–4%
Ocular hyperemia10%–5%10%–1%
Maculopathy10%–3%11%–3%
Dry eye10%–3%8%–5%
Ocular discomfort8%–0%5%–0%
Conjunctival hyperemia9%–0%7%–0%
Posterior capsule opacification8%–0%5%–0%

Clinical Studies Experience‑ Non‑Ocular Reactions

Table 2 shows the most frequently reported non-ocular adverse reactions that were reported with LUCENTIS treatment, for which the point estimates were higher in the LUCENTIS group compared with the control group. The ranges represent the maximum and minimum rates across all three studies for control, and across all three studies and both dose groups for LUCENTIS.

Table 2
Adverse ReactionLUCENTISControl
Hypertension/elevated blood pressure23%–5%23%–8%
Nasopharyngitis16%–5%13%–5%
Arthralgia11%–3%9%–0%
Headache15%–2%10%–3%
Bronchitis10%–3%8%–2%
Cough10%–3%7%–2%
Anemia8%–3%8%–0%
Nausea9%–2%6%–4%
Sinusitis8%–2%6%–4%
Influenza10%–2%5%–1%

The rate of arterial thromboembolic events in the three studies in the first year was 2.1% of patients (18 out of 874) in the combined group of patients treated with 0.3 mg or 0.5 mg LUCENTIS, compared with 1.1% of patients (5 out of 441) in the control arms of the studies. In the second year of Study 1, the rate of arterial thromboembolic events was 3.0% of patients (14 out of 466) in the combined group of patients treated with 0.3 mg or 0.5 mg LUCENTIS compared with 3.2% of patients (7 out of 216) in the control arm [see Warnings and Precautions].

Immunogenicity

The pre‑treatment incidence of immunoreactivity to LUCENTIS was 0%–3% across treatment groups. After monthly dosing with LUCENTIS for 12 to 24 months, low titers of antibodies to LUCENTIS were detected in approximately 1%–6% of patients. The immunogenicity data reflect the percentage of patients whose test results were considered positive for antibodies to LUCENTIS in an electrochemiluminescence assay and are highly dependent on the sensitivity and specificity of the assay. The clinical significance of immunoreactivity to LUCENTIS is unclear at this time, although some patients with the highest levels of immunoreactivity were noted to have iritis or vitritis.



REPORTS OF SUSPECTED LUCENTIS SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Lucentis. The information is not vetted and should not be considered as verified clinical evidence.

Possible Lucentis side effects / adverse reactions in 68 year old male

Reported by a health professional (non-physician/pharmacist) from Switzerland on 2011-10-11

Patient: 68 year old male

Reactions: Musculoskeletal Chest Pain

Suspect drug(s):
Lucentis



Possible Lucentis side effects / adverse reactions in 72 year old female

Reported by a health professional (non-physician/pharmacist) from Greece on 2011-10-12

Patient: 72 year old female

Reactions: Choroidal Haemorrhage

Suspect drug(s):
Lucentis



Possible Lucentis side effects / adverse reactions in 88 year old female

Reported by a consumer/non-health professional from United States on 2011-10-13

Patient: 88 year old female weighing 43.5 kg (95.8 pounds)

Reactions: Migraine, Transient Ischaemic Attack

Adverse event resulted in: life threatening event

Suspect drug(s):
Lucentis
    Dosage: 0.5 mg (single use vial) every 2 wks
    Indication: Macular Degeneration
    Start date: 2011-04-12

Lucentis
    Dosage: 0.5 mg (single use vial) every 2 wks
    Indication: Macular Degeneration
    Start date: 2011-03-02

Lucentis
    Dosage: 0.5 mg (single use vial) every 2 wks
    Indication: Macular Degeneration
    Start date: 2011-03-16

Lucentis
    Dosage: 0.5 mg (single use vial) every 2 wks
    Indication: Macular Degeneration
    Start date: 2011-03-31

Lucentis



See index of all Lucentis side effect reports >>

Drug label data at the top of this Page last updated: 2006-06-30

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2012