Thrombocytopenia

Adverse Reactions-

CNS-                               dizziness 17%     insomnia 16%   paresthesia 6%

GI -                                   abdominal pain  11%    dyspepsia  7%

Musculoskeletal -          arthalgia  26%      myalgia  14%     pain in extremity 13%
                                        shoulder pain  8%

Special Precautions-

Bone marrow effects-  romiplostim  administration increase the risk  for development of
progression of reticulum fiber deposition within the bone marrow.

Prior to initiation of romiplostim examine the peripheral blood smear closely to  establish a baseline
level of cellular morophologic abnormalites.

If the person develops new or worsening of morphological abnormalites or cytopenias, discontinue
treatment with romiplostin and consider a bone marrow biospy, including staining for fibrosis.  

Discontinuation- discontinuation of romiplostim may result in thrombocytopenia of greater severity
than was present prior to rompilostim therapy.
The worsened thrombocytopenia may increase the patients risk of bleeding,particularly if
romiplostim is discontinued while the patient is anticoagulants or antiplatelet agents.

Thrombotic /thromboembolic effects- thrombotic/thromboembolic complications may result from
excessive increase in platelet counts.
To minimise the risk of of thrombotic/thromboembolic complicatiions, do not use romiplostim
in an attempt to normalize platelet counts. Follow the dose adjustment guidelines to acheive  and
maintain a platelet count of at least 50* 10/ 9 L

Lack of response- Discontinue romiplostim if the platelet count does not increase to a level
sufficient to avoid clinically important bleeding after 4 week at the highest weekly dose of
10mcg/kg

Malignacies- romiplostim is not indicated for thetreatment of thrombocytopenia due to
MDS or any cause of thrombocytopenia other than chronic ITP.

Renal function impairment- use romiplostim with caution in such patients.

Hepatic function impairment-  use romiplostin with caution in such patients

Pregnancy-  use romiplostim during pregnancy only if this potential benefit to the mother justifies
the potential risk to the fetus.

Lactation- decide whether to discontinue breast-feeding or rompilostim taking into account the
importance of the drug to the mother and the known benefits of breast-feeding.

Children- Safety and effectiveness in children ( younger than 18 years ) have not been established.

Elderly- dose adjustment for an elderly patient should be cautious, reflecting greater frequency
of decreased hepatic, renal, cardiac function and of concomittant disease or other drug therapy.

Indication-
Thrombocytopenia

Dosage-
Use the lowest dose of romiplostin to acheive and maintain a platelet count of at least 50 * 10 9/L
as  necessary to reduce the risk of bleeding .
Romiplostin should not  be used to normalise platelet counts.

1. Prior to treatment, patients should fully understand the risks and benefits of romipoetim.
   Inform patients that the isks associated withlong term administration of romiplostim are unknown
   and they enrol in NEXUS program which provides for the proper use of romiplostim in
   ITP patients

2. Romiplostim can be dministrered by ahealth care provider who is enrolled in the romiplostim
   NEXUS program or ahealth care provider under their direction.

3. Romplostim therapy is administered to acheive and maintain a platelet count of at least
    50* 10 9/ L  as necessary to reduce the risk of bleeding , romplostim is not used to normalize
    platelet counts. 

4. Following discontinuation of romiplostim , thromboctopenia and risk of bleeding that is worse than
   experienced prior to the romiplostim therapy may develop.

5. Romiplostim therapy increases the risk of reticulin fiber formation within the bone marrow and
    futher fiber fiber formation may progress to marrow fibrosis. Detection of peripheral blood cell
    abnormalites may necessiates a bome marrow examination.

6. Too much romiplostim may result in excessive platelet counts and a risk for thrombotic/
    thromboembolic complications.

Pharmacology-
Romiplostim increases platelet production through binding and activation of the thrombopoietin
(TPO ) receptor a mechanism analogous to endogenous TPO.

Pregnancy- 
Use romiplostim during pregnancy only if this potential benefit to the mother justifies
the potential risk to the fetus.

Lactation-
Decide whether to discontinue breast-feeding or rompilostim taking into account the
importance of the drug to the mother and the known benefits of breast-feeding.

Children-
Safety and effectiveness in children ( younger than 18 years ) have not been established.

Elderly-
Dose adjustment for an elderly patient should be cautious , reflecting greater frequency
of decreased hepatic, renal, cardiac function and of concomittant disease or other drug therapy.