Question Categories
1. Drug Administration
Drug Administration Clarification:
Regarding drug administration and timing, please see protocol section 4.1.
· Marqibo is given over 60 minutes +\- 10 minutes
· Mitoxantrone will follow Marqibo administration (on day 1) and will be given over 5-15 minute, with dexrazoxane to be given immediately before mitoxantrone when given.
· Dexamethasone may be given IV if cannot tolerate PO, as per protocol section 6.2.4
· Timing of IT methotrexate is flexible in regards to timing of Marqibo.
__________________________________________________________________________________________________________________________________
Q. A central line is "suggested" for administration of mitoxantrone - can the drug be given through a peripheral IV if necessary?
A.YES, but care should be taken to avoid extravasation as mitoxantrone is an irritant.
– Section 6.3.4 –
“Mitoxantrone is an irritant: Care should be taken to avoid extravasation; the use of a central line is suggested. If it is known or suspected that subcutaneous extravasation has occurred, it is recommended that intermittent ice packs be placed over the area of extravasation and that the affected extremity be elevated. Because of the progressive nature of extravasation reactions, the area of injection should be frequently examined and surgery consultation obtained early if there is any sign of a local reaction.”
__________________________________________________________________________________________________________________________________
Q. Please clarify whether pegaspargase is to be given by IV or IM injection - the protocol states both options (section 4.1 says IM or IV, yet 6.5.4 only gives administration guidelines for IM injection).
A. Protocol has both options.
__________________________________________________________________________________________________________________________________
Q. Clarification on section 4.1 of the protocol regarding pegaspargase and the substitution of an equivalent dosing of Erwinia asparaginase dosing.
A. Protocol should read that the total INDIVIDUAL dose is not to exceed pegaspargase equivalent dosing of 3,750 IU (i.e., IU Erwinia).
__________________________________________________________________________________________________________________________________
Q. Please clarify whether a tablet of dexamethasone can be chewed/crushed?
A. Can use oral solution if needed. Can also crush or chew. It is up to the referring institution to decide which preparative regimen is best.
__________________________________________________________________________________________________________________________________
Q. Please clarify what to do if an oral dose of dexamethasone is vomited or missed. Please clarify the amount of time that is required between the two dexamethasone doses/day.
A. If vomited immediately and can see the tablet—re-dose. Otherwise it is missed. Approximately 8 hours (best times are generally breakfast and dinner to prevent GI irritation.)
__________________________________________________________________________________________________________________________________
Q. Is there a specific timeframe for vomited dose? I.e. re-dose if patient vomited within 30 minutes of dosing?
A. Regarding vomiting up dexamethosone: if emesis is within 10 minutes of dosing or if tablets can be visualized then re-dose. Otherwise just give it at the next scheduled dose. (Combine with the above vomiting question.)
__________________________________________________________________________________________________________________________________
Q. Please confirm that local institutional guidelines can be used for dose calculations and dose rounding for chemotherapy agents including Marqibo.
A. . The amount (in mg) of study drug to be administered will be determined based on body surface area (BSA). In calculating BSA, actual height obtained at screening and weights obtained at the onset of induction should be used. There will be no adjustment to “ideal” body weight. See protocol pg. 30.
__________________________________________________________________________________________________________________________________
Q. Is dose rounding to the nearest tenth or per institutional standards (for Marqibo® dosing)?
A.The nearest tenth is preferred.
Q. Please clarify whether or not a patient should receive gut prophylaxis while receiving steroids - there are no suggestions in "supportive care".
A. It is not required, but can be considered based on patient need.
__________________________________________________________________________________________________________________________________
2. Drug Preparation and Ordering
Q. Can you clarify the inversion instruction on the infusion label?
A. Although it says, ‘Invert 5 times immediately prior to infusion’ on the infusion label, the intention is for the bag to be gently inverted 5 x at the pharmacy, not at the patient’s bedside.”
__________________________________________________________________________________________________________________________________
Q. Will Spectrum/TACL supply our investigational pharmacy services with any special equipment to prepare Marqibo; it suggests in some of the paperwork that we need a special waterbath/temperature gauge. Can you confirm? If so, how/when will that be supplied?
A. Yes, Spectrum will supply the water bath and related equipment with the first drug order (see order form).
______________________________