Sargramostim interacts in the following cases:
Patients receiving both sargramostim and medicinal products that induce leucocytosis (e.g., corticosteroids, other colony-stimulating factors, lithium) may have an increased risk of leucocytosis.
There is no data available on sargramostim and human fertility. Studies in rabbits have shown adverse effects on female fertility.
In patients with pre-existing pleural and pericardial effusions, administration of sargramostim may aggravate fluid retention. Fluid retention associated with or worsened by sargramostim has been reversible after interruption or dose reduction of sargramostim with or without diuretic therapy.
Imreplys should be used with caution in patients with pre-existing fluid retention, pulmonary infiltrates, or congestive heart failure. Body weight and hydration status should be carefully monitored during sargramostim administration.
Supraventricular arrhythmia has been reported in uncontrolled studies during sargramostim administration in haematological conditions, particularly in patients with a previous history of cardiac arrhythmia. These arrhythmias have been reversible after discontinuation of treatment. Sargramostim should be used with caution in patients with pre-existing cardiac disease. A physician or other health care professional should be consulted if any new or worsening arrhythmia is observed.
Acute exposure to myelosuppressive doses of radiation has per se a toxic effect on fertility and embryo/foetal development. This should be considered for clinical judgement on the use of Imreplys in pregnant women.
There are no or limited data on the use of sargramostim in pregnant women. Studies in animals have shown reproductive toxicity.
Sargramostim can be used in pregnant women with H-ARS if clinically needed.
Acute exposure to myelosuppressive doses of radiation has per se a toxic effect on fertility and embryo/foetal development. This should be considered for clinical judgement on the use of Imreplys in lactating women.
It is unknown whether sargramostim/metabolites are excreted in human milk. A risk to the suckling child cannot be excluded.
Breast-feeding may be considered during treatment with sargramostim, keeping in mind that the newborns may also need treatment.
There is no data available on sargramostim and human fertility. Studies in rabbits have shown adverse effects on female fertility.
Sargramostim has no or negligible influence on the ability to drive and use machines.
The safety of sargramostim was evaluated using all available sources, including clinical studies in adults and children across various indications, healthy human volunteer studies, solicited and unsolicited reports, and literature-reported events.
The most serious adverse drug reactions (ADR) that occurred during sargramostim treatment were:
The most common ADRs observed in haematological cancer patients treated with intravenously administered sargramostim are: fever (without infection; up to 95%), diarrhoea (up to 88%), vomiting (up to 84%), skin reactions (up to 77%), rash (up to 70%), asthenia (up to 69%), metabolic laboratory abnormalities (up to 58%), malaise (up to 58%), high glucose (up to 49%), abdominal pain (up to 38%), weight loss (up to 37%), low albumin (up to 36%), pruritis (up to 23%), GI haemorrhage (up to 27%), chills (up to 25%), pharyngitis (up to 23%), bone pain (up to 21%), chest pain (up to 15%), hypomagnesaemia (up to 15%), haematemesis (up to 13%), arthralgia (joint pain; up to 11%), anxiety (up to 11%), eye haemorrhage (up to 11%). In some subjects, the underlying diseases may have contributed to the occurrence of those ADRs.
The tabulated ADRs table is based on 5 clinical studies in 182 patients with haematological cancers where WBC are affected similarly to what occurs during acute exposure to myelosuppressive doses of radiation. In these studies, sargramostim was administered intravenously.
The adverse reactions are listed by MedDRA system organ class and categories of frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1 000 to <1/100), rare (≥1/10 000 to <1/1 000), very rare (<1/10 000) and not known (cannot be estimated from the available data).
Table 1. Adverse reactions reported in adults and children with haematological cancers treated with intravenous sargramostim in controlled clinical studies:
| System Organ Class (MedDRA) | Very common | Common | Uncommon | Rare | Very rare |
|---|---|---|---|---|---|
| Nervous system disorders | Anxiety | ||||
| Eye disorders | Eye haemorrhage | ||||
| Vascular disorders | Vasodilation | ||||
| Respiratory, thoracic and mediastinal disorders | Pharyngitis | ||||
| Gastrointestinal disorders | Abdominal pain Diarrhoea Gastrointestinal haemorrhage Haematemesis Vomiting | ||||
| Skin and subcutaneous tissue disorders | Pruritis Rash Skin reactions | ||||
| Musculoskeletal and connective tissue disorders | Bone pain Arthralgia | ||||
| General disorders and administration site conditions | Asthenia Chest pain Chills Fever (no infection) Malaise Weight loss | ||||
| Investigations | High glucose Low albumin Hypomagnesaemia Metabolic function test abnormalities NOS |
A total of 332 paediatric subjects were treated with intravenous sargramostim in 15 clinical studies in haematological conditions, premature neonates and Crohn's disease of which 5 were controlled, 190 patients were 0-1 month of age, 6 patients were >1 month to <2 years of age, 1 patient was <1 year of age (not otherwise specified), 86 patients were 2 to <12 years of age, and 49 patients were 12 to <18 years of age. The overall safety profile was similar to that seen in adults.
Additional ADRs have been observed in clinical studies in healthy adult volunteers and children with Crohn's disease, where the majority of patients were administered sargramostim via the subcutaneous route. From these studies, in addition to Table 1, ADRs include injection site reactions (up to 91%), headache (up to 50%) back pain, (up to 47%), nausea (up to 23%), abdominal cramps (up to 17%), dyspnoea (up to 12%), and general body pain (up to 13%).
The most common ADRs were pyrexia, injection site reaction, dyspnoea, nausea, chest pain, vomiting, diarrhoea, chills, rash, hypotension, abdominal pain, febrile neutropenia, sepsis, pneumonia, dizziness, and syncope.
Serious hypersensitivity reactions including anaphylaxis, haemodynamic oedema, effusions and fluid overload and supraventricular arrhythmias have been reported with the use of sargramostim in various health conditions.
No overall differences in safety profile are observed between reports from adult and paediatric populations.
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