Peripheral neuropathy (or paraesthesiae)

Peripheral neuropathy Lenalidomide is structurally related to thalidomide, which is known to induce severe peripheral neuropathy.

tremor, headache seizures, disturbances in consciousness, paraesthesias and dysaesthesias, peripheral neuropathies, dizziness, writing impaired, nervous system disorders 8

tremor, headache seizures, disturbances in consciousness, paraesthesias and dysaesthesias, peripheral neuropathies, dizziness, writing impaired, nervous system disorders 22

tremor, headache seizures, disturbances in consciousness, paraesthesias and dysaesthesias, peripheral neuropathies, dizziness, writing impaired, nervous system disorders 36

tremor, headache seizures, disturbances in consciousness, paraesthesias and dysaesthesias, peripheral neuropathies, dizziness, writing impaired, nervous system disorders

Treatment should be directed at the major anticipated toxicities, which are bone marrow suppression, mucositis and peripheral neuropathy.

Peripheral neuropathy, characterised by paresthesia dysesthesia, is a common and well known effect of environmental arsenic.

There have also been reports of events associated with demyelination, and ascending peripheral neuropathies similar in appearance to Guillain Barré Syndrome.

There have also been reports of events associated with demyelination and ascending peripheral neuropathies similar in appearance to Guillain Barré syndrome.

In multi cycle general toxicity studies conducted in the rat and monkey, the principal target organs included the gastrointestinal tract, resulting in vomiting and or diarrhoea haematopoietic and lymphatic tissues, resulting in peripheral blood cytopenias, lymphoid tissue atrophy and haematopoietic bone marrow hypocellularity peripheral neuropathy (observed in monkeys, mice and dogs) involving sensory nerve axons and mild changes in the kidneys.

In multi cycle general toxicity studies conducted in the rat and monkey, the principal target organs included the gastrointestinal tract, resulting in vomiting and or diarrhoea, haematopoietic and lymphatic tissues resulting in peripheral blood cytopenias, lymphoid tissue atrophy and hematopoietic bone marrow hypocellularity peripheral neuropathy (observed in monkeys, mice and dogs) involving sensory nerve axons and mild changes in the kidneys.

Facial palsy, neuropathies, mononeuropathies

Facial palsy, neuropathies (including mononeuropathies)

2 Patients who experience bortezomib related neuropathic pain and or peripheral neuropathy are to be managed as presented in Table 1 (see section 4.4).

Patients who experience bortezomib related neuropathic pain and or peripheral neuropathy are to be managed as presented in Table 1 (see section 4.4).

Peripheral motor 0.7 ) neuropathy (G3 4

peripheral neuropathy, peripheral sensory neuropathy (see section 4.4),

These events have included altered mental states including severe somnolence, central nervous system effects including convulsions, and peripheral neuropathy ranging from numbness and paresthesias to motor weakness and paralysis.

Nervous system disorders Very rare ( 1 10,000) Paresthesia, paralysis (Bell's palsy), peripheral neuropathies (polyradiculoneuritis, facial paralysis), neuritis (including Guillain Barre Syndrome, optical neuritis, myelitis including transverse myelitis), encephalitis, demyelinating disease of the central nervous system, exacerbation of multiple sclerosis, multiple sclerosis, seizure, headache, dizziness, syncope

peripheral neuropathy

Cerebrovascular accident Syncope Somnolence Headache

Peripheral neuropathy

Oedema peripheral

Peripheral oedema

Common

Peripheral neuropathy

Peripheral ischaemia

In paediatric patients peripheral oedema

Peripheral neuropathy

0 (0 ) 0 (0 ) 0 (0 ) 0 (0 )

Between 5 and 7 (best estimate 6) for 5 years use

Uncommon peripheral neuropathy.

Peripheral demyelinating disorders (such as Guillain Barré syndrome, chronic inflammatory demyelinating polyneuropathy and multifocal motor neuropathy), central nervous system demyelinating disorders (such as optic neuritis), transverse myelitis, seizure, neuropathy, hypoaesthesia, paraesthesia Eye disorders Uncommon

Peripheral oedema, thirst

General disorders and administration site condition asthenia, peripheral oedema.

Pulmonary oedema Peripheral oedema

fatigue, peripheral oedema

fatigue peripheral oedema

depression

Seizure, peripheral neuropathy

Uncommon oedema, oedema peripheral, fever, wound secretion

e ris In other studies or in post marketing experience, rare cases of intracranial intracerebral and retroperitoneal bleedings have been reported.

Somnolence

Hypertension Peripheral ischaemia, hypotension