Case Study 9

For each question, choose the answer you think is correct. Answers are provided at the end of the page.
​S.M. is a 70-year-old female diagnosed with metastatic melanoma with bilateral pulmonary nodules and a mass in the left pelvis; BRAF mutation positive. Given her age and comorbidities, she was deemed to be a candidate for the SMAVIPI protocol.

Lab results taken 24 hours prior to first treatment:
Lab value
Patient's labs
Normal range 
WBC
5.5
4 – 10 x 109/L
ANC
3.2
2 – 7.5 x 109/L
Hgb
125
115 – 155 g/L
Plt
349
150 – 400 x 109/L
SCr
71
45 – 90 µmol/L​
eGFR
75
≥ 60 mL/min/1.73m2
TSH
0.36
0.32 – 5.04 mU/L
AM Cortisol
250
125 – 536 nmol/L
AST
6
<36 U/L
ALT
8
<36 U/L
ALP
77
35 – 120 U/L
Total bilirubin
6
<17 µmol/L​​​
LD
148
<225 U/L

Weight = 62.1 kg, Height = 160 cm

1. Which of the following best describes the BC Cancer benefit status of ipilimumab?

  1. It is a Class I drug and does not require special approval prior to treatment
  2. It is a Class I drug and special approval must be obtained prior to treatment
  3. It is a restricted drug but does not require special approval prior to treatment
  4. It is a restricted drug and case-by-case Compassionate Access Program (CAP) approval must be obtained prior to treatment

2. Which of the following would be the most appropriate dose calculation of ipilimumab for S.M.?

  1. 4.98 mg
  2. 498 mg
  3. 186 mg
  4. 1860 mg

3. Which pre-medications should S.M. receive prior to her first dose of ipilimumab?

  1. diphenhydrAMINE 50 mg PO 30 minutes prior to treatment
  2. acetaminophen 325 - 975 mg PO 30 minutes prior to treatment
  3. hydrocortisone 25 mg IV 30 minutes prior to treatment
  4. All of the above
  5. None of the above

4. Which of the following best describes the safe handling precautions for ipilimumab?

  1. It is not a hazardous drug and can be mixed by the RN in the treatment room
  2. It is not a hazardous drug but should be mixed in pharmacy as per local standards of non-hazardous drug sterile compounding
  3. It is a hazardous drug and should be mixed in pharmacy as per local standards of hazardous drug sterile compounding
  4. It is a biohazardous drug and extreme precautions should be taken in pharmacy when compounding

5.  On the day of her 3rd cycle of SMAVIPI, S.M. calls the clinic and reports having 4 to 6 loose bowel movements per day over the last few days. Her normal number of bowel movements is 1 per day. She has been taking loperamide with no improvement. What would you recommend?

  1. Proceed with ipilimumab treatment today, as planned, at the same dose
  2. Proceed with ipilimumab treatment today, as planned, but at a reduced dose
  3. Hold ipilimumab treatment today, and ask her physician to assess for immune-related enterocolitis which may require corticosteroid treatment with predniSONE
  4. Hold ipilimumab treatment today, and ask her physician to assess for immune-related enterocolitis which may require antibiotic treatment with vancomycin

 
The correct answer is 1.

Rationale: According to the BC Cancer Benefit Drug List, ipilimumab is a Class I drug when used as first-line treatment of unresectable or metastatic melanoma (SMAVFIPI) or for the treatment of advanced and metastatic melanoma after prior systemic therapy (SMAVIPI).


 
The correct answer is 3.

Rationale: Ipilimumab dosing is calculated using weight and not BSA. According to the SMAVIPI protocol, it is given at 3 mg/kg and therefore, the calculated dose would be 186 mg. This calculated dose would then be dose banded to 200 mg per the protocol's Ipilimumab Dose Banding Table (1-10 mg/kg with no capped dose) appendix.

 
The correct answer is 5.

Rationale: According to the SMAVIPI PPPO and protocol, options 1, 2, and 3 are required only in the case of a prior infusion reaction. They are not required prior to a first dose of ipilimumab.


 
The correct answer is 2.

Rationale: According to the BC Cancer and NIOSH Hazardous Drug lists, ipilimumab is not a hazardous drug and therefore can be prepared as per local standards of sterile non-hazardous drug compounding.

 
The correct answer is 3.

Rationale: Based on her symptoms, S.M. is experiencing Grade 2 diarrhea which has not resolved despite antidiarrheal treatment. According to the Enterocolitis chart located at the end of the SCIMMUNE protocol, ipilimumab should be withheld until her symptoms resolve to Grade 1 or lower. She should also be assessed to rule out any infectious etiology, and may need to be started on immunosuppressive corticosteroid treatment with predniSONE 0.5 to 1 mg/kg/day PO if the problem persists beyond 3 to 5 days or recurs.

 

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