Pelgraz

Clear, colourless solution for injection.
Pelgraz 6 mg solution for injection in pre-filled syringe/injector: Each pre-filled syringe contains 6 mg of pegfilgrastim* in 0.6 mL solution for injection. The concentration is 10 mg/mL based on protein only**.
*Produced in Escherichia coli cells by recombinant DNA technology followed by conjugation with polyethylene glycol (PEG).
** The concentration is 20 mg/mL if the PEG moiety is included.
The potency of this medicinal product should not be compared to the potency of another pegylated or non-pegylated protein of the same therapeutic class. For more information, see Pharmacology: Pharmacodynamics under Actions.
Excipients with known effect: Each pre-filled syringe or pre-filled injector contains 30 mg sorbitol (E420) (see Precautions).
Excipients/Inactive Ingredients: Sodium acetate*, Sorbitol (E420), Polysorbate 20, Water for injections.
*Sodium acetate is formed by titrating glacial acetic acid with sodium hydroxide.

Pharmacotherapeutic group: Immunostimulants, colony stimulating factor. ATC Code: L03AA13.
Pharmacology: Pharmacodynamics: Pelgraz is a biosimilar medicinal product.
Human granulocyte-colony stimulating factor (G-CSF) is a glycoprotein, which regulates the production and release of neutrophils from the bone marrow. Pegfilgrastim is a covalent conjugate of recombinant human G-CSF (r-metHuG-CSF) with a single 20 kd PEG molecule. Pegfilgrastim is a sustained duration form of filgrastim due to decreased renal clearance. Pegfilgrastim and filgrastim have been shown to have identical modes of action, causing a marked increase in peripheral blood neutrophil counts within 24 hours, with minor increases in monocytes and/or lymphocytes. Similarly to filgrastim, neutrophils produced in response to pegfilgrastim show normal or enhanced function as demonstrated by tests of chemotactic and phagocytic function. As with other haematopoietic growth factors, G-CSF has shown in vitro stimulating properties on human endothelial cells. G-CSF can promote growth of myeloid cells, including malignant cells, in vitro and similar effects may be seen on some non-myeloid cells in vitro.
In two randomised, double-blind, pivotal studies in patients with high-risk stage II-IV breast cancer undergoing myelosuppressive chemotherapy consisting of doxorubicin and docetaxel, use of pegfilgrastim, as a single once per cycle dose, reduced the duration of neutropenia and the incidence of febrile neutropenia similarly to that observed with daily administrations of filgrastim (a median of 11 daily administrations). In the absence of growth factor support, this regimen has been reported to result in a mean duration of grade 4 neutropenia of 5 to7 days, and a 30-40% incidence of febrile neutropenia. In one study (n=157), which used a 6 mg fixed dose of pegfilgrastim the mean duration of grade 4 neutropenia for the pegfilgrastim group was 1.8 days compared with 1.6 days in the filgrastim group (difference 0.23 days, 95% CI -0.15, 0.63). Over the entire study, the rate of febrile neutropenia was 13% of pegfilgrastim-treated patients compared with 20% of filgrastim-treated patients (difference 7%, 95% CI of -19%, 5%). In a second study (n=310), which used a weight adjusted dose (100 mcg/kg), the mean duration of grade 4 neutropenia for the pegfilgrastim group was 1.7 days, compared with 1.8 days in the filgrastim group (difference 0.03 days, 95% CI -0.36, 0.30). The overall rate of febrile neutropenia was 9% of patients treated with pegfilgrastim and 18% of patients treated with filgrastim (difference 9%, 95% CI of -16.8%,-1.1%).
In a placebo-controlled, double-blind study in patients with breast cancer the effect of pegfilgrastim on the incidence of febrile neutropenia was evaluated following administration of a chemotherapy regimen associated with a febrile neutropenia rate of 10-20% (docetaxel 100 mg/m² every 3 weeks for 4 cycles). Nine hundred and twenty eight-patients were randomised to receive either a single dose of pegfilgrastim or placebo approximately 24 hours (day 2) after chemotherapy in each cycle. The incidence of febrile neutropenia was lower for patients randomised to receive pegfilgrastim compared with placebo (1% versus 17%, p <0.001). The incidence of hospitalisations and intravenous anti-infective use associated with a clinical diagnosis of febrile neutropenia was lower in the pegfilgrastim group compared with placebo (1% versus 14%, p <0.001; and 2% versus 10%, p <0.001).
A small (n=83), phase II, randomised, double-blind study in patients receiving chemotherapy for de novo AML compared pegfilgrastim (single dose of 6 mg) with filgrastim, administered during induction chemotherapy. Median time to recovery from severe neutropenia was estimated as 22 days in both treatment groups. Long term-outcome was not studied (see Precautions).
In a phase II (n=37) multicentre, randomised, open-label study of paediatric sarcoma patients receiving 100 mcg/kg pegfilgrastim following cycle 1 of vincristine, doxorubicin and cyclophosphamide (VAdriaC/IE) chemotherapy, a longer duration of severe neutropenia (neutrophils <0.5 × 10⁹/L) was observed in younger children aged 0-5 years (8.9 days) compared to older children aged 6-11 years and 12-21 years (6 days and 3.7 days, respectively) and adults. Additionally a higher incidence of febrile neutropenia was observed in younger children aged 0-5 years (75%) compared to older children aged 6-11 years and 12-21 years (70% and 33%, respectively) and adults (see Adverse Reactions and Pharmacology: Pharmacokinetics under Actions).
Pharmacokinetics: After a single subcutaneous dose of pegfilgrastim, the peak serum concentration of pegfilgrastim occurs at 16 to 120 hours after dosing and serum concentrations of pegfilgrastim are maintained during the period of neutropenia after myelosuppressive chemotherapy. The elimination of pegfilgrastim is non-linear with respect to dose; serum clearance of pegfilgrastim decreases with increasing dose.
Pegfilgrastim appears to be mainly eliminated by neutrophil-mediated clearance, which becomes saturated at higher doses. Consistent with a self-regulating clearance mechanism, the serum concentration of pegfilgrastim declines rapidly at the onset of neutrophil recovery (see Figure).

Click on icon to see table/diagram/image

Due to the neutrophil-mediated clearance mechanism, the pharmacokinetics of pegfilgrastim is not expected to be affected by renal or hepatic impairment. In an open-label, single dose study (n=31) various stages of renal impairment, including end-stage renal disease, had no impact on the pharmacokinetics of pegfilgrastim.
Elderly: Limited data indicate that the pharmacokinetics of pegfilgrastim in elderly subjects (>65 years) is similar to that in adults.
Paediatric population: The pharmacokinetics of pegfilgrastim were studied in 37 paediatric patients with sarcoma, who received 100 mcg/kg pegfilgrastim after the completion of VAdriaC/IE chemotherapy. The youngest age group (0-5 years) had a higher mean exposure to pegfilgrastim (AUC) (± Standard Deviation) (47.9 ± 22.5 mcg·hr/ml) than older children aged 6-11 years and 12-21 years (22.0 ± 13.1 mcg·hr/mL and 29.3 ± 23.2 mcg·hr/mL, respectively) (see Pharmacology: Pharmacodynamics under Actions). With the exception of the youngest age group (0-5 years), the mean AUC in paediatric subjects appeared similar to that for adult patients with high-risk stage II-IV breast cancer and receiving 100 mcg/kg pegfilgrastim after the completion of doxorubicin/docetaxel (see Adverse Reactions and Pharmacology: Pharmacodynamics under Actions).
Toxicology: Preclinical safety data: Preclinical data from conventional studies of repeated dose toxicity revealed the expected pharmacological effects including increases in leukocyte count, myeloid hyperplasia in bone marrow, extramedullary haematopoiesis and splenic enlargement.
There were no adverse effects observed in offspring from pregnant rats given pegfilgrastim subcutaneously, but in rabbits pegfilgrastim has been shown to cause embryo/foetal toxicity (embryo loss) at cumulative doses approximately 4 times the recommended human dose, which were not seen when pregnant rabbits were exposed to the recommended human dose. In rat studies, it was shown that pegfilgrastim may cross the placenta. Studies in rats indicated that reproductive performance, fertility, oestrous cycling, days between pairing and coitus, and intrauterine survival were unaffected by pegfilgrastim given subcutaneously. The relevance of these findings for humans is not known.

Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).

Pelgraz therapy should be initiated and supervised by physicians experienced in oncology and/or haematology.
Posology: One 6 mg dose (a single pre-filled syringe or pre-filled injecton) of Pelgraz is recommended for each chemotherapy cycle, given at least 24 hours after cytotoxic chemotherapy.
Special populations: Paediatric population: The safety and efficacy of Pelgraz in children and adolescents has not yet been established. Currently available data are described in sections Adverse Reactions, Pharmacology: Pharmacodynamics and Pharmacokinetics under Actions but no recommendation on a posology can be made.
Patients with renal impairment: No dose change is recommended in patients with renal impairment, including those with end-stage renal disease.
Method of administration: Pelgraz is for subcutaneous use. The injections should be given subcutaneously into the thigh, abdomen or upper arm.
For instructions on handling of the medicinal product before administration, see Cautions for Usage.

Single doses of 300 mcg/kg have been administered subcutaneously to a limited number of healthy volunteers and patients with non-small cell lung cancer without serious adverse reactions. The adverse reactions were similar to those in subjects receiving lower doses of pegfilgrastim.

Hypersensitivity to the active substance or to any of the excipients listed in Descriptions.

Traceability: In order to improve the traceability of biological medicinal products, the trade name of the administered product should be clearly recorded.
Acute myeloid leukaemia (AML): Limited clinical data suggest a comparable effect on time to recovery of severe neutropenia for pegfilgrastim to filgrastim in patients with de novo AML (see Pharmacology: Pharmacodynamics under Actions). However, the long-term effects of pegfilgrastim have not been established in AML; therefore, it should be used with caution in this patient population.
G-CSF can promote growth of myeloid cells in vitro and similar effects may be seen on some non-myeloid cells in vitro.
The safety and efficacy of pegfilgrastim have not been investigated in patients with myelodysplastic syndrome, chronic myelogenous leukaemia, and in patients with secondary AML; therefore, it should not be used in such patients. Particular care should be taken to distinguish the diagnosis of blast transformation of chronic myeloid leukaemia from AML.
The safety and efficacy of pegfilgrastim administration in de novo AML patients aged <55 years with cytogenetics t(15;17) have not been established.
The safety and efficacy of pegfilgrastim have not been investigated in patients receiving high dose chemotherapy. This medicinal product should not be used to increase the dose of cytotoxic chemotherapy beyond established dose regimens.
Pulmonary adverse reactions: Pulmonary adverse reactions, in particular interstitial pneumonia, have been reported after G-CSF administration. Patients with a recent history of pulmonary infiltrates or pneumonia may be at higher risk (see Adverse Reactions).
The onset of pulmonary signs such as cough, fever, and dyspnoea in association with radiological signs of pulmonary infiltrates, and deterioration in pulmonary function along with increased neutrophil count may be preliminary signs of adult respiratory distress syndrome (ARDS). In such circumstances pegfilgrastim should be discontinued at the discretion of the physician and the appropriate treatment given (see Adverse Reactions).
Glomerulonephritis: Glomerulonephritis has been reported in patients receiving filgrastim and pegfilgrastim. Generally, events of glomerulonephritis resolved after dose reduction or withdrawal of filgrastim and pegfilgrastim. Urinalysis monitoring is recommended.
Capillary leak syndrome: Capillary leak syndrome has been reported after G-CSF administration and is characterised by hypotension, hypoalbuminaemia, oedema and haemoconcentration. Patients who develop symptoms of capillary leak syndrome should be closely monitored and receive standard symptomatic treatment, which may include a need for intensive care (see Adverse Reactions).
Splenomegaly and splenic rupture: Generally asymptomatic cases of splenomegaly and cases of splenic rupture, including some fatal cases, have been reported following administration of pegfilgrastim (see Adverse Reactions). Therefore, spleen size should be carefully monitored (e.g. clinical examination, ultrasound). A diagnosis of splenic rupture should be considered in patients reporting left upper abdominal pain or shoulder tip pain.
Thrombocytopenia and anaemia: Treatment with pegfilgrastim alone does not preclude thrombocytopenia and anaemia because full dose myelosuppressive chemotherapy is maintained on the prescribed schedule. Regular monitoring of platelet count and haematocrit is recommended. Special care should be taken when administering single or combination chemotherapeutic medicinal products which are known to cause severe thrombocytopenia.
Myelodysplastic syndrome and acute myeloid leukaemia in breast and lung cancer patients: In the post-marketing observational study setting, pegfilgrastim in conjunction with chemotherapy and/or radiotherapy has been associated with development of myelodysplastic syndrome (MDS) and acute myeloid leukaemia (AML) in breast and lung cancer patients (see Adverse Reactions). Monitor breast and lung cancer patients for signs and symptoms of MDS/AML.
Sickle cell anaemia: Sickle cell crises have been associated with the use of pegfilgrastim in patients with sickle cell trait or sickle cell disease (see Adverse Reactions). Therefore, physicians should use caution when prescribing pegfilgrastim in patients with sickle cell trait or sickle cell disease, should monitor appropriate clinical parameters and laboratory status and be attentive to the possible association of this medicinal product with splenic enlargement and vaso-occlusive crisis.
Leukocytosis: White blood cell (WBC) counts of 100 × 10⁹/L or greater have been observed in less than 1% of patients receiving pegfilgrastim. No adverse reactions directly attributable to this degree of leukocytosis have been reported. Such elevation in WBCs is transient, typically seen 24 to 48 hours after administration and is consistent with the pharmacodynamic effects of this medicinal product. Consistent with the clinical effects and the potential for leukocytosis, a WBC count should be performed at regular intervals during therapy. If leukocyte counts exceed 50 × 10⁹/L after the expected nadir, this medicinal product should be discontinued immediately.
Hypersensitivity: Hypersensitivity, including anaphylactic reactions, occurring on initial or subsequent treatment have been reported in patients treated with pegfilgrastim. Permanently discontinue pegfilgrastim in patients with clinically significant hypersensitivity. Do not administer pegfilgrastim to patients with a history of hypersensitivity to pegfilgrastim or filgrastim. If a serious allergic reaction occurs, appropriate therapy should be administered, with close patient follow-up over several days.
Stevens-Johnson syndrome: Stevens-Johnson syndrome (SJS), which can be life-threatening or fatal, has been reported rarely in association with pegfilgrastim treatment. If the patient has developed SJS with the use of pegfilgrastim, treatment with pegfilgrastim must not be restarted in this patient at any time.
Immunogenicity: As with all therapeutic proteins, there is a potential for immunogenicity. Rates of generation of antibodies against pegfilgrastim is generally low. Binding antibodies do occur as expected with all biologics; however, they have not been associated with neutralising activity at present.
Aortitis: Aortitis has been reported after filgrastim or pegfilgrastim administration in healthy subjects and in cancer patients. The symptoms experienced included fever, abdominal pain, malaise, back pain and increased inflammatory markers (e.g. C-reactive protein and WBC count). In most cases aortitis was diagnosed by CT scan and generally resolved after withdrawal of filgrastim or pegfilgrastim. See also Adverse Reactions.
Mobilisation of PBPC: The safety and efficacy of Pelgraz for the mobilisation of blood progenitor cells in patients or healthy donors has not been adequately evaluated.
Other special precautions: Increased haematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone-imaging findings. This should be considered when interpreting bone-imaging results.
Excipients with known effect: Sorbitol: The additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account.
Sodium: Pelgraz contains less than 1 mmol sodium (23 mg) per 6 mg dose, that is to say essentially 'sodium-free'.
All patients: The needle cover of the pre-filled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions.
Effects on ability to drive and use machines: Pegfilgrastim has no or negligible influence on the ability to drive and use machines.

Pregnancy: There are no or limited amount of data from the use of pegfilgrastim in pregnant women. Studies in animals have shown reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions). Pegfilgrastim is not recommended during pregnancy and in women of childbearing potential not using contraception.
Breast-feeding: There is insufficient information on the excretion of pegfilgrastim/metabolites in human milk, a risk to the newborns/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from pegfilgrastim therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Fertility: Pegfilgrastim did not affect reproductive performance or fertility in male or female rats at cumulative weekly doses approximately 6 to 9 times higher than the recommended human dose (based on body surface area) (see Pharmacology: Toxicology: Preclinical safety data under Actions).

Summary of the safety profile: The most frequently reported adverse reactions were bone pain (very common [≥1/10]) and musculoskeletal pain (common [≥1/100 to <1/10]). Bone pain was generally of mild to moderate severity, transient and could be controlled in most patients with standard analgesics.
Hypersensitivity-type reactions, including skin rash, urticaria, angioedema, dyspnoea, erythaema, flushing, and hypotension occurred on initial or subsequent treatment with pegfilgrastim (uncommon [≥1/1,000 to <1/100]). Serious allergic reactions, including anaphylaxis can occur in patients receiving pegfilgrastim (uncommon) (see Precautions).
Capillary Leak Syndrome, which can be life-threatening if treatment is delayed, has been reported as uncommon (≥1/1,000 to <1/100) in cancer patients undergoing chemotherapy following administration of G-CSFs; see Precautions and Description of selected adverse reactions as follows.
Splenomegaly, generally asymptomatic, is uncommon.
Splenic rupture including some fatal cases is uncommonly reported following administration of pegfilgrastim (see Precautions).
Uncommon pulmonary adverse reactions including interstitial pneumonia, pulmonary oedema, pulmonary infiltrates and pulmonary fibrosis have been reported. Uncommonly, cases have resulted in respiratory failure or ARDS, which may be fatal (see Precautions).
Isolated cases of sickle cell crises have been reported in patients with sickle cell trait or sickle cell disease (uncommon in sickle cell patients) (see Precautions).
Tabulated list of adverse reactions: The data in the table as follows describe adverse reactions reported from clinical trials and spontaneous reporting. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. (See Table.)

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Description of selected adverse reactions: Uncommon cases of Sweet's syndrome have been reported, although in some cases underlying haematological malignancies may play a role.
Uncommon events of cutaneous vasculitis have been reported in patients treated with pegfilgrastim. The mechanism of vasculitis in patients receiving pegfilgrastim is unknown.
Injection site reactions, including injection site erythaema (uncommon) as well as injection site pain (common events) have occurred on initial or subsequent treatment with pegfilgrastim.
Common cases of leukocytosis (WBC > 100 × 10⁹/L) have been reported (see Precautions).
Reversible, mild to moderate elevations in uric acid and alkaline phosphatase, with no associated clinical effects, were uncommon; reversible, mild to moderate elevations in lactate dehydrogenase, with no associated clinical effects, were uncommon in patients receiving pegfilgrastim following cytotoxic chemotherapy.
Nausea and headaches were very commonly observed in patients receiving chemotherapy.
Uncommon elevations in liver function tests (LFTs) for alanine aminotransferase (ALT) or aspartate aminotransferase (AST), have been observed in patients after receiving pegfilgrastim following cytotoxic chemotherapy. These elevations are transient and return to baseline.
An increased risk of MDS/AML following treatment with Pelgraz in conjunction with chemotherapy and/or radiotherapy has been observed in an epidemiological study in breast and lung cancer patients (see Precautions).
Common cases of thrombocytopenia have been reported.
Cases of capillary leak syndrome have been reported in the post-marketing setting with G-CSF use. These have generally occurred in patients with advanced malignant diseases, sepsis, taking multiple chemotherapy medicinal products or undergoing apheresis (see Precautions).
Paediatric population: The experience in children is limited. A higher frequency of serious adverse reactions in younger children aged 0-5 years (92%) has been observed compared to older children aged 6-11 and 12-21 years respectively (80% and 67%) and adults. The most common adverse reaction reported was bone pain (see Pharmacology: Pharmacodynamics and Pharmacokinetics under Actions).
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.

Due to the potential sensitivity of rapidly dividing myeloid cells to cytotoxic chemotherapy, pegfilgrastim should be administered at least 24 hours after administration of cytotoxic chemotherapy. In clinical trials, pegfilgrastim has been safely administered 14 days before chemotherapy. Concomitant use of Pelgraz with any chemotherapeutic medicinal product has not been evaluated in patients. In animal models concomitant administration of pegfilgrastim and 5-fluorouracil (5-FU) or other antimetabolites has been shown to potentiate myelosuppression.
Possible interactions with other haematopoietic growth factors and cytokines, has not been specifically investigated in clinical trials.
The potential for interaction with lithium, which also promotes the release of neutrophils, has not been specifically investigated. There is no evidence that such an interaction would be harmful.
The safety and efficacy of Pelgraz have not been evaluated in patients receiving chemotherapy associated with delayed myelosuppression e.g. nitrosoureas.
Specific interaction or metabolism studies have not been performed, however, clinical trials have not indicated an interaction of pegfilgrastim with any other medicinal products.

Special precautions for disposal and other handling: Pelgraz 6 mg solution for injection in pre-filled syringe: Before use, Pelgraz solution should be inspected visually for particulate matter. Only a solution that is clear and colourless should be injected.
Excessive shaking may aggregate pegfilgrastim, rendering it biologically inactive.
Allow the pre-filled syringe to reach room temperature for 30 minutes before injecting.
Using the pre filled syringe with a needle safety guard: The needle safety guard covers the needle after injection to prevent needle stick injury. This does not affect normal operation of the syringe. The plunger should be slowly and evenly depressed until the entire dose has been given and the plunger cannot be depressed any further. While maintaining pressure on the plunger, the syringe should be removed from the injection site. The needle safety guard will cover the needle when releasing the plunger.
Pelgraz 6 mg solution for injection in pre-filled injector: Before use, Pelgraz solution should be inspected visually for particulate matter. Only a solution that is clear and colourless should be injected.
Excessive shaking may aggregate pegfilgrastim, rendering it biologically inactive.
Allow the pre-filled injector to reach room temperature for 30 minutes before injecting.
Disposal: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Incompatibilities: This medicinal product must not be mixed with other medicinal products, particularly with sodium chloride solutions.

Store in a refrigerator (2°C-8°C).
Pelgraz may be exposed to room temperature (not above 25°C±2°C) for a maximum single period of up to 72 hours. Pelgraz left at room temperature for more than 72 hours should be discarded.
Do not freeze. Accidental exposure to freezing temperatures for a single period of less than 24 hours does not adversely affect the stability of Pelgraz.
Keep the container in the outer carton in order to protect from light.
Shelf life: 3 years:

What Pelgraz is and what it is used for: Pelgraz contains the active substance pegfilgrastim. Pegfilgrastim is a protein produced by biotechnology in bacteria called E. coli. It belongs to a group of proteins called cytokines, and is very similar to a natural protein (granulocyte-colony stimulating factor) produced by your own body.
Pelgraz is used to reduce the duration of neutropenia (low white blood cell count) and the occurrence of febrile neutropenia (low white blood cell count with a fever) which can be caused by the use of cytotoxic chemotherapy (medicines that destroy rapidly growing cells). White blood cells are important as they help your body fight infection. These cells are very sensitive to the effects of chemotherapy which can cause the number of these cells in your body to decrease. If white blood cells fall to a low level there may not be enough left in the body to fight bacteria and you may have an increased risk of infection.
Your doctor has given you Pelgraz to encourage your bone marrow (part of the bone which makes blood cells) to produce more white blood cells that help your body fight infection.
How to use Pelgraz: Pelgraz is for use in adults aged 18 and over.
Always take Pelgraz exactly as your doctor has told you. You should check with your doctor or pharmacist if you are unsure. The usual dose is one 6 mg subcutaneous injection (injection under your skin) using a pre-filled syringe and it should be given at least 24 hours after your last dose of chemotherapy at the end of each chemotherapy cycle.
Do not shake Pelgraz vigorously as this may affect its activity.
Injecting Pelgraz yourself: Your doctor may decide that it would be more convenient for you to inject Pelgraz yourself. Your doctor or nurse will show you how to inject yourself. Do not try to inject yourself unless you have received special training from your doctor or nurse.
The instructions how to inject yourself are given as follows, but proper treatment of your disease requires close and constant co-operation with your doctor.
If you are not sure about giving yourself the injection or you have any questions, please ask your doctor or nurse for help.
How do I inject Pelgraz myself: You will need to give yourself the injection into the tissue just under the skin. This is known as a subcutaneous injection.
Equipment that you need: To give yourself a subcutaneous injection you will need: a pre-filled syringe of Pelgraz; alcohol swab.
What should I do before I give myself a subcutaneous injection of Pelgraz: Take the pre-filled syringe out of the refrigerator.
Do not remove the needle cover from the syringe until just before you are ready to inject.
Check the expiry date on the pre-filled syringe label (EXP). Do not use it if the date has passed the last day of the month shown or if it has been kept outside of the refrigerator for more than 72 hours or has otherwise expired.
Check the appearance of Pelgraz. It must be a clear and colourless liquid. If there are particles in it, you must not use it.
For a more comfortable injection, let the pre-filled syringe stand for 30 minutes to reach room temperature or hold the pre-filled syringe gently in your hand for a few minutes. Do not warm Pelgraz in any other way (for example, do not warm it in a microwave or in hot water).
Wash your hands thoroughly.
Find a comfortable, well-lit place and put everything you need where you can reach them (the pre-filled syringe and alcohol swab).
How do I prepare my Pelgraz injection: Before you inject Pelgraz you must do the following: 1. Hold the syringe and gently take the cover from the needle without twisting. Pull straight. Do not touch the needle or push the plunger.
2. You may notice a small air bubble in the pre-filled syringe. You do not have to remove the air bubble before injecting. Injecting the solution with the air bubble is harmless.
3. You can now use the pre-filled syringe.
Where should I give my injection: The most suitable places to inject yourself are: the top of your thighs; and the abdomen, except for the area around the navel.
If someone else is injecting you, they can also use the back of your arms.
It is better to change the injection site every time to avoid the risk of soreness at any one site.
How do I give my injection: a. Disinfect the injection site by using an alcohol swab and pinch the skin between your thumb and forefinger, without squeezing it.
Pre-filled syringe with needle safety guard: b. Put the needle fully into the skin as shown by your nurse or doctor.
c. Pull slightly on the plunger to check that a blood vessel has not been punctured. If you see blood in the syringe, remove the needle and re-insert it in another place.
d. Always keeping your skin pinched, depress the plunger slowly and evenly while grasping the finger flange until the entire dose has been given and the plunger cannot be depressed any further. Do not release the pressure on the plunger.
e. After injecting the liquid, while keeping the syringe at the same angle and maintaining pressure on the plunger, remove the needle and then let go of your skin. The protective sleeve will automatically cover the needle and an audible "click" will be heard to confirm shield activation. The needle guard will not activate unless the entire dose has been given.
Remember: If you have any problems, please ask your doctor or nurse for help and advice.
Disposing of used syringes: Dispose of the syringe as instructed by your doctor, pharmacist or nurse.
If you use more Pelgraz than you should: If you use more Pelgraz than you should contact your doctor, pharmacist or nurse.
If you forget to inject Pelgraz: If you are injecting yourself and have forgotten your dose of Pelgraz, you should contact your doctor to discuss when you should inject the next dose.
If you stop using Pelgraz: Your doctor will tell you when to stop using Pelgraz. It is quite normal to have a number of courses of treatment with Pelgraz.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Haematopoietic Agents / Supportive Care Therapy

L03AA13 - pegfilgrastim ; Belongs to the class of colony stimulating factors. Used as immunostimulants.

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